// Biotech and Pharma Therapeutics
Adamis, Harpoon, Neoleukin and Tricida add to biotech layoff wave as pipeline setbacks spur cuts
November 15, 2022 / Adamis / Tricida / Layoffs / Restructuring –If anyone needed a reminder of the toll the bear market continues to take on biotech, the wave of layoffs announced by companies postmarket yesterday should leave them in no doubt. Adamis Pharmaceuticals, Harpoon Therapeutics, Neoleukin Therapeutics and Tricida all outlined plans to lay off staff in response to financial headaches and stuttering drug development pipelines. Read Full Article on Fierce Biotech>>
November 15, 2022 / Adamis / Tricida / Layoffs / Restructuring –If anyone needed a reminder of the toll the bear market continues to take on biotech, the wave of layoffs announced by companies postmarket yesterday should leave them in no doubt. Adamis Pharmaceuticals, Harpoon Therapeutics, Neoleukin Therapeutics and Tricida all outlined plans to lay off staff in response to financial headaches and stuttering drug development pipelines. Read Full Article on Fierce Biotech>>
Eli Lilly’s Julie Gilmore on finding up-and-coming companies and backing small biotechs
November 15, 2022 / Eli Lilly / New Deal / Pipeline / San Francisco – A 150-year-old pharmaceutical giant may not sound like the cutting edge of biotech innovation. But like many of its peers, Eli Lilly looks to young companies to help build its pipeline. And that focus has intensified in recent years, with a growing network of incubators aimed at reaching further into the startup world. In 2019, it launched Lilly Gateway Labs in an effort to dip into the San Francisco Bay Area’s biotech scene, one of the largest centers of life sciences startup activity in the country. Read Full Article on Biopharma Dive >>
November 15, 2022 / Eli Lilly / New Deal / Pipeline / San Francisco – A 150-year-old pharmaceutical giant may not sound like the cutting edge of biotech innovation. But like many of its peers, Eli Lilly looks to young companies to help build its pipeline. And that focus has intensified in recent years, with a growing network of incubators aimed at reaching further into the startup world. In 2019, it launched Lilly Gateway Labs in an effort to dip into the San Francisco Bay Area’s biotech scene, one of the largest centers of life sciences startup activity in the country. Read Full Article on Biopharma Dive >>
New SEC charges allege insider trading related to Merck’s acquisition of Pandion was a family affair
November 11, 2022 / Merck & Co / Pandion Therapeutics / Insider Trading / Securities and Exchange Commission –The Securities and Exchange Commission (SEC) alleges that Brian Wong made $400,000 after being tipped off to the deal early by his brother Brandon, according to a new complaint (PDF) unsealed in federal court on Thursday. Brandon was originally charged with insider trading along with his friend and former FBI trainee Seth Markin back in July. That complaint alleged that Brandon and Markin made $1.3 million and $800,000, respectively, ahead of the February 2021 offer after Markin secretly reviewed material about the acquisition held by his then-romantic partner who worked as a lawyer on the deal. After getting a sneak peek at the details, Markin tipped off Brandon to the opportunity, the feds claim. Read Full Article on Fierce Biotech>>
November 11, 2022 / Merck & Co / Pandion Therapeutics / Insider Trading / Securities and Exchange Commission –The Securities and Exchange Commission (SEC) alleges that Brian Wong made $400,000 after being tipped off to the deal early by his brother Brandon, according to a new complaint (PDF) unsealed in federal court on Thursday. Brandon was originally charged with insider trading along with his friend and former FBI trainee Seth Markin back in July. That complaint alleged that Brandon and Markin made $1.3 million and $800,000, respectively, ahead of the February 2021 offer after Markin secretly reviewed material about the acquisition held by his then-romantic partner who worked as a lawyer on the deal. After getting a sneak peek at the details, Markin tipped off Brandon to the opportunity, the feds claim. Read Full Article on Fierce Biotech>>
Roche’s ‘high risk’ failure has industry circling the wagons on future of Alzheimer’s research
November 15, 2022 / Roche / Alzheimer’s Disease / Gantenerumab / Crenezumab –Another failure of an amyloid medicine for Alzheimer’s disease has companies, analysts and patient advocacy groups circling the wagons to once again defend the theory and the future of research into the devastating neurological disorder. The theory that reducing or preventing amyloid plaques in the brain can slow cognitive decline has time and time again failed in the clinic, with the very notable exception of one recent effort, that is: Eisai and Biogen’s lecanemab scored a surprise win in a phase 3 study in late September by proving it could slow cognitive decline by 27% compared to placebo. Read Full Article on Fierce Biotech >>
November 15, 2022 / Roche / Alzheimer’s Disease / Gantenerumab / Crenezumab –Another failure of an amyloid medicine for Alzheimer’s disease has companies, analysts and patient advocacy groups circling the wagons to once again defend the theory and the future of research into the devastating neurological disorder. The theory that reducing or preventing amyloid plaques in the brain can slow cognitive decline has time and time again failed in the clinic, with the very notable exception of one recent effort, that is: Eisai and Biogen’s lecanemab scored a surprise win in a phase 3 study in late September by proving it could slow cognitive decline by 27% compared to placebo. Read Full Article on Fierce Biotech >>
AstraZeneca poised to lock horns with Merck, BMS and more as Imjudo-Imfinzi combo snags lung cancer approval
November 11, 2022 / AstraZeneca / Imfinzi / Tremelimumab / non-small cell lung cancer –After years on the back foot, AstraZeneca’s immunotherapy tag team of Imjudo and Imfinzi has pinned down its second indication in less than a month. The U.S. FDA has signed off on the combo alongside platinum-based chemotherapy for adults with metastatic non-small cell lung cancer (NSCLC), AstraZeneca said Friday. The green light comes right on the heels of Imjudo’s first approval in October—also in tandem with Imfinzi—in unresectable hepatocellular carcinoma, the most common type of liver cancer. Read Full Article on Fierce Pharma >>
November 11, 2022 / AstraZeneca / Imfinzi / Tremelimumab / non-small cell lung cancer –After years on the back foot, AstraZeneca’s immunotherapy tag team of Imjudo and Imfinzi has pinned down its second indication in less than a month. The U.S. FDA has signed off on the combo alongside platinum-based chemotherapy for adults with metastatic non-small cell lung cancer (NSCLC), AstraZeneca said Friday. The green light comes right on the heels of Imjudo’s first approval in October—also in tandem with Imfinzi—in unresectable hepatocellular carcinoma, the most common type of liver cancer. Read Full Article on Fierce Pharma >>
// 4th Industrial Revolution
A New Wearable Measures Brain Activity
November 11, 2022 / Brain / Wearable / New Health –If you’ve ever had a brain scan, or even just seen one on TV, you probably know that it’s kind of a big deal. Measuring brain activity usually involves functional magnetic resonance imaging (fMRI) — that’s when the patient goes into the big humming tube — or electroencephalography (EEG), in which electrodes are attached to the scalp. It could also mean electrocorticography (ECoG), a surgical procedure in which an electrode is placed under the scalp. But what if there was a much simpler way to measure brain activity? One that doesn’t require a clinical setting, much less an invasive surgery? There just might be. Researchers at Japan’s Osaka University have developed an EEG wearable that can measure brain activity in everyday settings. Light, stretchable, and transparent, the sheet-type sensor attaches to the forehead to wirelessly monitor brain waves, recording EEGs, without physical discomfort for the wearer. And with accuracy that’s comparable to medical-grade equipment, according to the findings of a study published in Advanced Materials Technologies. The study’s lead author Teppei Araki says, “We were able to fuse together organic and inorganic materials to create a stretchable and transparent sensor sheet that can be worn on the forehead, is gentle to the skin, and is invisible to the eye. Unlike conventional wearable devices, our multifunctional electrode system has medical device-like performance, is easy to apply, and is comfortable to wear for long periods of time.” Read Full Health Tech Insider >>
November 11, 2022 / Brain / Wearable / New Health –If you’ve ever had a brain scan, or even just seen one on TV, you probably know that it’s kind of a big deal. Measuring brain activity usually involves functional magnetic resonance imaging (fMRI) — that’s when the patient goes into the big humming tube — or electroencephalography (EEG), in which electrodes are attached to the scalp. It could also mean electrocorticography (ECoG), a surgical procedure in which an electrode is placed under the scalp. But what if there was a much simpler way to measure brain activity? One that doesn’t require a clinical setting, much less an invasive surgery? There just might be. Researchers at Japan’s Osaka University have developed an EEG wearable that can measure brain activity in everyday settings. Light, stretchable, and transparent, the sheet-type sensor attaches to the forehead to wirelessly monitor brain waves, recording EEGs, without physical discomfort for the wearer. And with accuracy that’s comparable to medical-grade equipment, according to the findings of a study published in Advanced Materials Technologies. The study’s lead author Teppei Araki says, “We were able to fuse together organic and inorganic materials to create a stretchable and transparent sensor sheet that can be worn on the forehead, is gentle to the skin, and is invisible to the eye. Unlike conventional wearable devices, our multifunctional electrode system has medical device-like performance, is easy to apply, and is comfortable to wear for long periods of time.” Read Full Health Tech Insider >>
Patients want more info about clinical trials. Here’s how biopharma can help
November 14, 2022 / Patient Help / Biopharma –Enrolling clinical trials quickly can make a big difference in cutting the time it takes for patients to access new therapies and enabling sponsors to leapfrog rivals in the race to market. But while the industry has yet to address a fundamental barrier to enrollment—low patient knowledge of clinical trials—the good news is that patients are interested in learning more. Patients want more information about clinical trials, and biopharma now has the tools to reach them, new data from Phreesia Life Sciences suggests. A Phreesia survey of more than 4,000 people found that more than two-thirds (68%) of surveyed patients said they were interested in learning more about trials. Full Article on Fierce Biotech >>
November 14, 2022 / Patient Help / Biopharma –Enrolling clinical trials quickly can make a big difference in cutting the time it takes for patients to access new therapies and enabling sponsors to leapfrog rivals in the race to market. But while the industry has yet to address a fundamental barrier to enrollment—low patient knowledge of clinical trials—the good news is that patients are interested in learning more. Patients want more information about clinical trials, and biopharma now has the tools to reach them, new data from Phreesia Life Sciences suggests. A Phreesia survey of more than 4,000 people found that more than two-thirds (68%) of surveyed patients said they were interested in learning more about trials. Full Article on Fierce Biotech >>
Covenant Health uses telemedicine to get specialists to rural areas – and much more
November 15, 2022 / Covenant Health / Telemedicine / Affordable Care –Covenant Health began its journey with telehealth a decade prior to the COVID-19 pandemic and served as a pioneer in the region in virtual care. The health system’s telehealth stroke program was begun in 2012, developing the region’s first comprehensive stroke center. “This technology, coupled with virtual viewing of medical imaging, allowed Covenant Health neuro-hospitalists to assist ED physicians with rapid diagnoses and urgent treatment of stroke patients,” said Dr. Mandy Halford, senior vice president and chief medical informatics officer at Covenant Health. Read Article on Healthcare IT News >>
November 15, 2022 / Covenant Health / Telemedicine / Affordable Care –Covenant Health began its journey with telehealth a decade prior to the COVID-19 pandemic and served as a pioneer in the region in virtual care. The health system’s telehealth stroke program was begun in 2012, developing the region’s first comprehensive stroke center. “This technology, coupled with virtual viewing of medical imaging, allowed Covenant Health neuro-hospitalists to assist ED physicians with rapid diagnoses and urgent treatment of stroke patients,” said Dr. Mandy Halford, senior vice president and chief medical informatics officer at Covenant Health. Read Article on Healthcare IT News >>
New AMA blueprint seeks to tap the full potential of digital health
November 14, 2022 / AMA / Digital Healthcare – More than $100 billion of venture funding has been invested in digital health companies since 2010, but that investment has not addressed healthcare’s greatest needs, according to the AMA report. “Despite this decade of progress, the U.S. healthcare system has very little to show for it – in the past 10 years, we have made minimal progress in addressing ongoing healthcare challenges of access, quality, outcomes, affordability and equity, even with the introduction of promising new digital health tools. In short, digital health to date has not lived up to its fullest potential,” said AMA officials. Achieving the promise of digitally enabled health requires healthcare stakeholders to adopt the six pillars and work in partnership. Read Full Article on Healthcare IT News >>
November 14, 2022 / AMA / Digital Healthcare – More than $100 billion of venture funding has been invested in digital health companies since 2010, but that investment has not addressed healthcare’s greatest needs, according to the AMA report. “Despite this decade of progress, the U.S. healthcare system has very little to show for it – in the past 10 years, we have made minimal progress in addressing ongoing healthcare challenges of access, quality, outcomes, affordability and equity, even with the introduction of promising new digital health tools. In short, digital health to date has not lived up to its fullest potential,” said AMA officials. Achieving the promise of digitally enabled health requires healthcare stakeholders to adopt the six pillars and work in partnership. Read Full Article on Healthcare IT News >>
LG Launches Virtual Care Solution with Amwell to Address Hospital Workforce Shortages
November 14, 2022 / Virtual Care / Hospital Workforce Shortage – LG Electronics USA, Inc., based in Englewood Cliffs, N.J., is the North American subsidiary of LG Electronics, Inc., a $63 billion global innovator in technology and manufacturing. In the United States, LG sells a wide range of innovative home appliances, home entertainment products, commercial displays, air conditioning systems, energy solutions and vehicle components. LG is 2022 ENERGY STAR® Partner of the Year-Sustained Excellence. The company’s commitment to environmental sustainability and its “Life’s Good” marketing theme encompass how LG is dedicated to people’s happiness by exceeding expectations today and tomorrow. Read Full Article on HIT Consultant >>
November 14, 2022 / Virtual Care / Hospital Workforce Shortage – LG Electronics USA, Inc., based in Englewood Cliffs, N.J., is the North American subsidiary of LG Electronics, Inc., a $63 billion global innovator in technology and manufacturing. In the United States, LG sells a wide range of innovative home appliances, home entertainment products, commercial displays, air conditioning systems, energy solutions and vehicle components. LG is 2022 ENERGY STAR® Partner of the Year-Sustained Excellence. The company’s commitment to environmental sustainability and its “Life’s Good” marketing theme encompass how LG is dedicated to people’s happiness by exceeding expectations today and tomorrow. Read Full Article on HIT Consultant >>
// Business & Markets
Adapting to the patient: personalization and value in an evolving market
November 14, 2022 / Pharma / Real Chemistry / Healthcare – A big role, if you ask Chuck Hemann, president of Integrated Activation at Real Chemistry, and Bill Veltrie, director of Omni-Channel Experience, Strategy, and Planning at Bristol Myers Squibb. Rebecca Willumson, publisher of Fierce Pharma, asked that very question. Customer and patient expectations are evolving—we are entering the “Amazonification of healthcare”, and the COVID-19 pandemic has only accelerated that change. In this era of patient personalization, pharma companies must adapt. Awareness tactics like linear television ads aren’t enough, and technology is increasingly at the center of these efforts. Read Full Article on Fierce Pharma >>
November 14, 2022 / Pharma / Real Chemistry / Healthcare – A big role, if you ask Chuck Hemann, president of Integrated Activation at Real Chemistry, and Bill Veltrie, director of Omni-Channel Experience, Strategy, and Planning at Bristol Myers Squibb. Rebecca Willumson, publisher of Fierce Pharma, asked that very question. Customer and patient expectations are evolving—we are entering the “Amazonification of healthcare”, and the COVID-19 pandemic has only accelerated that change. In this era of patient personalization, pharma companies must adapt. Awareness tactics like linear television ads aren’t enough, and technology is increasingly at the center of these efforts. Read Full Article on Fierce Pharma >>
AstraZeneca and Sanofi win big as Europe’s human medicines committee endorses approvals, label expansions
November 14, 2022 / AstraZeneca / Sanofi / GSK / Regeneron Pharma –Cancer, COVID-19 and copycat drugs dominated the agenda at last week’s meeting of the European Medicines Agency’s (EMA’s) human medicines committee, which has endorsed four new pharmaceuticals and pushed for label extensions on 11 others. AstraZeneca and Sanofi were the biggest winners this time around, nabbing three and four approval recommendations, respectively. The EMA’s Committee for Medicinal Products for Human Use (CHMP) also put its chips behind drugs and vaccines from GSK, Roche, Viatris, Regeneron and Bayer, among others. Read Full Article on Fierce Pharma >>
November 14, 2022 / AstraZeneca / Sanofi / GSK / Regeneron Pharma –Cancer, COVID-19 and copycat drugs dominated the agenda at last week’s meeting of the European Medicines Agency’s (EMA’s) human medicines committee, which has endorsed four new pharmaceuticals and pushed for label extensions on 11 others. AstraZeneca and Sanofi were the biggest winners this time around, nabbing three and four approval recommendations, respectively. The EMA’s Committee for Medicinal Products for Human Use (CHMP) also put its chips behind drugs and vaccines from GSK, Roche, Viatris, Regeneron and Bayer, among others. Read Full Article on Fierce Pharma >>
Ionis, Metagenomi pen Big Pharma-sized genetic target pact that could total almost $3B
November 14, 2022 / Cell & Gene Therapy / Metagenomi / Inois / Gene Editing – The gargantuan financial deal is astounding for two companies that are not heralded as large pharmas, but nonetheless, the announcement shows just how much the industry is betting on gene editing. The agreement is essentially split into two groups of four possible genetic targets—Ionis is paying $80 million for the first batch of four, with two of the targets being co-developed with Metagenomi. If or when the first of those targets is submitted to regulators to enter clinical trials, Ionis will have the chance to sign up to four additional targets, Metagenomi Chief Investment Officer and SVP of Strategy Simon Harnest explained in an interview with Fierce Biotech. The upfront cost to sign onto all four additional targets would be $120 million. In total, there are almost $3 billion in biobucks available spanning all eight potential targets, which, for comparison, exceeds recent deals from some of the world’s largest pharma companies. Read Full Article on Fierce Biotech >>
November 14, 2022 / Cell & Gene Therapy / Metagenomi / Inois / Gene Editing – The gargantuan financial deal is astounding for two companies that are not heralded as large pharmas, but nonetheless, the announcement shows just how much the industry is betting on gene editing. The agreement is essentially split into two groups of four possible genetic targets—Ionis is paying $80 million for the first batch of four, with two of the targets being co-developed with Metagenomi. If or when the first of those targets is submitted to regulators to enter clinical trials, Ionis will have the chance to sign up to four additional targets, Metagenomi Chief Investment Officer and SVP of Strategy Simon Harnest explained in an interview with Fierce Biotech. The upfront cost to sign onto all four additional targets would be $120 million. In total, there are almost $3 billion in biobucks available spanning all eight potential targets, which, for comparison, exceeds recent deals from some of the world’s largest pharma companies. Read Full Article on Fierce Biotech >>
Narcan developer to be acquired by Indivior
November 14, 2022 / Narcan / Indivior / Nasal Formulation – Opiant Pharmaceuticals, developer of the opioid overdose treatment Narcan, has agreed to be bought by the specialty drug company Indivior in an all-cash deal announced Monday. The deal has already been approved by the boards of directors of both companies, and is expected to close by the end of March. Terms hold that Indivior will pay $20 up front for each outstanding share of Opiant, reflecting a 111% premium to the target’s share price on Friday.
Read Full Article on Biopharma Dive >>
November 14, 2022 / Narcan / Indivior / Nasal Formulation – Opiant Pharmaceuticals, developer of the opioid overdose treatment Narcan, has agreed to be bought by the specialty drug company Indivior in an all-cash deal announced Monday. The deal has already been approved by the boards of directors of both companies, and is expected to close by the end of March. Terms hold that Indivior will pay $20 up front for each outstanding share of Opiant, reflecting a 111% premium to the target’s share price on Friday.
Read Full Article on Biopharma Dive >>
Promise of mRNA technology creates new manufacturing challenges
November 14, 2022 / mRNA / Manufacturing / Vaccines / Therapeutics – Vaccines to prevent SARS-CoV-2 infection were not the first attempt at utilizing the promise of mRNA in a therapeutic setting. From the discovery of mRNA in the 1960s, many scientists, clinicians, and patients have contributed findings and advancements that provided the knowledge and experience necessary to rapidly progress from sequencing of SARS-CoV-2 to emergency use authorizations for mRNA-based COVID-19 vaccines. For example, mRNA is rapidly degraded once produced inside the cell to provide protection against detrimental protein build up and only provide protein during a relatively short timeframe. This presents a problem when limitations in protein production hinder the proper immune response to vaccine treatment. However, scientists have not only figured out ways to deliver exogenous mRNA inside a cell, but they have also added features to increase longevity of mRNA translation to allow enough protein to be produced for a therapeutic effect.
Read Full Article on Fierce Biotech >>
November 14, 2022 / mRNA / Manufacturing / Vaccines / Therapeutics – Vaccines to prevent SARS-CoV-2 infection were not the first attempt at utilizing the promise of mRNA in a therapeutic setting. From the discovery of mRNA in the 1960s, many scientists, clinicians, and patients have contributed findings and advancements that provided the knowledge and experience necessary to rapidly progress from sequencing of SARS-CoV-2 to emergency use authorizations for mRNA-based COVID-19 vaccines. For example, mRNA is rapidly degraded once produced inside the cell to provide protection against detrimental protein build up and only provide protein during a relatively short timeframe. This presents a problem when limitations in protein production hinder the proper immune response to vaccine treatment. However, scientists have not only figured out ways to deliver exogenous mRNA inside a cell, but they have also added features to increase longevity of mRNA translation to allow enough protein to be produced for a therapeutic effect.
Read Full Article on Fierce Biotech >>
// Legal & Regulatory
AbbVie inks $54M settlement to resolve Namenda ‘pay-for-delay’ lawsuit
November 15, 2022 / AbbVie / Allergan / Forest Laboratories / Namenda –The Illinois-based pharma giant agreed to pay $54.4 million to settle a 2015 class action lawsuit filed by health plans who said they overpaid for Namenda because of a 2010 settlement that allowed Forest Laboratories, now a part of AbbVie, to hold off generic competition to the drug until 2015. Forest signed that deal with Germany’s Merz Pharma. Years later, insurers and health plans called foul, alleging anticompetitive conduct. Now, the U.S. District Court for the Southern District of New York has granted its preliminary approval of the settlement. Read on Fierce Pharma >>
November 15, 2022 / AbbVie / Allergan / Forest Laboratories / Namenda –The Illinois-based pharma giant agreed to pay $54.4 million to settle a 2015 class action lawsuit filed by health plans who said they overpaid for Namenda because of a 2010 settlement that allowed Forest Laboratories, now a part of AbbVie, to hold off generic competition to the drug until 2015. Forest signed that deal with Germany’s Merz Pharma. Years later, insurers and health plans called foul, alleging anticompetitive conduct. Now, the U.S. District Court for the Southern District of New York has granted its preliminary approval of the settlement. Read on Fierce Pharma >>
Ardelyx FDA docs portend another showdown at this week’s expert hearing on kidney disease prospect
November 15, 2022 / Ardelyx / Ibsrela / US FDA – In briefing documents published Monday, staff reviewers from the FDA’s cardiology and nephrology division questioned the overall efficacy of Ardelyx’s NHE3 inhibitor tenapanor, which debuted in irritable bowel syndrome in April under the brand name Ibsrela. In chronic kidney disease (CKD), tenapanor works by reducing serum phosphorus, which often builds up in CKD patients in a condition known as hyperphosphatemia. In certain patients, high phosphate levels can cause blood calcium levels to drop, potentially leading to muscle cramps or spasms, rashes, bone and joint pain, and more. Read on Fierce Pharma >>
November 15, 2022 / Ardelyx / Ibsrela / US FDA – In briefing documents published Monday, staff reviewers from the FDA’s cardiology and nephrology division questioned the overall efficacy of Ardelyx’s NHE3 inhibitor tenapanor, which debuted in irritable bowel syndrome in April under the brand name Ibsrela. In chronic kidney disease (CKD), tenapanor works by reducing serum phosphorus, which often builds up in CKD patients in a condition known as hyperphosphatemia. In certain patients, high phosphate levels can cause blood calcium levels to drop, potentially leading to muscle cramps or spasms, rashes, bone and joint pain, and more. Read on Fierce Pharma >>
For ImmunoGen, persistence pays off as FDA clears ovarian cancer drug
November 15, 2022 / ImmunoGen / Women’s Heath / FDA –The Food and Drug Administration has approved a new drug for ovarian cancer in a decision that gives its developer, ImmunoGen, the first wholly owned, marketed medicine in its 41-year history. The regulator’s decision late Monday makes the drug, known as Elahere, the first new treatment available for ovarian cancer in more than seven years. It’s also a conditional approval that ImmunoGen will have to maintain by confirming Elahere’s benefits in further testing. A study is currently underway and expected to produce results early next year. Read on Biopharma Dive >>
November 15, 2022 / ImmunoGen / Women’s Heath / FDA –The Food and Drug Administration has approved a new drug for ovarian cancer in a decision that gives its developer, ImmunoGen, the first wholly owned, marketed medicine in its 41-year history. The regulator’s decision late Monday makes the drug, known as Elahere, the first new treatment available for ovarian cancer in more than seven years. It’s also a conditional approval that ImmunoGen will have to maintain by confirming Elahere’s benefits in further testing. A study is currently underway and expected to produce results early next year. Read on Biopharma Dive >>
In Jazz case, FTC urges court to delist patent on blockbuster Xyrem
November 14, 2022 / Jazz Pharma / Avadel Pharma / FTC / Xyrem – As Jazz Pharmaceuticals works to hold off forthcoming competition to its top-selling drug, antitrust regulators in the U.S. government are calling out its tactics. In a court filing (PDF), the U.S. Federal Trade Commission (FTC) took issue with a Jazz patent that covers a system for distributing Jazz’s twice-nightly narcolepsy drug Xyrem under an FDA-required program to curb treatment-related risks. Read on Fierce Pharma >>
November 14, 2022 / Jazz Pharma / Avadel Pharma / FTC / Xyrem – As Jazz Pharmaceuticals works to hold off forthcoming competition to its top-selling drug, antitrust regulators in the U.S. government are calling out its tactics. In a court filing (PDF), the U.S. Federal Trade Commission (FTC) took issue with a Jazz patent that covers a system for distributing Jazz’s twice-nightly narcolepsy drug Xyrem under an FDA-required program to curb treatment-related risks. Read on Fierce Pharma >>
Pfizer musters J&J, PhRMA’s support in closely watched Vyndaqel copay assistance case at Supreme Court
November 15, 2022 / Pfizer / Johnson & Johnson / Janssen / PhRMA –After an appeals court snubbed Pfizer’s proposed copay assistance programs for costly heart meds Vyndaqel and Vyndamax, the New York pharma turned to the Supreme Court. Now, as it awaits the justices’ decision on whether they’ll hear the case, Pfizer’s bid to challenge U.S. anti-kickback laws has garnered the attention of industry giants. Monday, trade group PhRMA, plus Johnson & Johnson and prescription coupon administrator TrialCard, fired off three separate amicus briefs backing Pfizer’s cause. Read on Fierce Pharma >>
November 15, 2022 / Pfizer / Johnson & Johnson / Janssen / PhRMA –After an appeals court snubbed Pfizer’s proposed copay assistance programs for costly heart meds Vyndaqel and Vyndamax, the New York pharma turned to the Supreme Court. Now, as it awaits the justices’ decision on whether they’ll hear the case, Pfizer’s bid to challenge U.S. anti-kickback laws has garnered the attention of industry giants. Monday, trade group PhRMA, plus Johnson & Johnson and prescription coupon administrator TrialCard, fired off three separate amicus briefs backing Pfizer’s cause. Read on Fierce Pharma >>
// Research & Development
Daiichi Sankyo, playing COVID catch up with Pfizer and Moderna, says its mRNA booster stands out
November 15, 2022 / Daiichi Sankyo / COVID-19 / Pfizer / Moderna – A booster dose of the company’s mRNA shot, DS-5670, increased neutralizing antibodies to higher levels than the shots already approved in Japan, the company reported Tuesday. Daiichi Sankyo says no safety concerns were identified and that more data would be presented at future conferences and in medical papers. The company will now ask Japanese regulators for approval in January 2023. It’s also gearing up for clinical trials of a bivalent vaccine, including strains of both the original virus and omicron variant. The company did not say whether it plans to ask other foreign regulators for booster consideration next year. Read Full Article on Fierce Biotech>>
November 15, 2022 / Daiichi Sankyo / COVID-19 / Pfizer / Moderna – A booster dose of the company’s mRNA shot, DS-5670, increased neutralizing antibodies to higher levels than the shots already approved in Japan, the company reported Tuesday. Daiichi Sankyo says no safety concerns were identified and that more data would be presented at future conferences and in medical papers. The company will now ask Japanese regulators for approval in January 2023. It’s also gearing up for clinical trials of a bivalent vaccine, including strains of both the original virus and omicron variant. The company did not say whether it plans to ask other foreign regulators for booster consideration next year. Read Full Article on Fierce Biotech>>
Liver enzyme elevations in healthy volunteers prompts soul searching at Surrozen
November 15, 2022 / Surrozen / Liver Disease / Adverse Events / Eye Disease – Healthy volunteers in Surrozen’s two phase 1 clinical trials have experienced treatment-related adverse events, leading to a voluntary pause on one study and some soul searching on the biotech’s financial resources and research priorities. The voluntary enrollment pause for the early-stage trial of SZN-1326 was announced postmarket Monday as Surrozen issued third-quarter earnings. The biotech made the decision after elevated liver enzymes were noted in several subjects. Although the cases were asymptomatic, high levels of alanine transaminase and aspartate transaminase can signal liver damage. Surrozen said the elevations were listed as grade 3, but no serious adverse events were reported. The trial began in May. Read Full Article on Fierce Biotech >>
November 15, 2022 / Surrozen / Liver Disease / Adverse Events / Eye Disease – Healthy volunteers in Surrozen’s two phase 1 clinical trials have experienced treatment-related adverse events, leading to a voluntary pause on one study and some soul searching on the biotech’s financial resources and research priorities. The voluntary enrollment pause for the early-stage trial of SZN-1326 was announced postmarket Monday as Surrozen issued third-quarter earnings. The biotech made the decision after elevated liver enzymes were noted in several subjects. Although the cases were asymptomatic, high levels of alanine transaminase and aspartate transaminase can signal liver damage. Surrozen said the elevations were listed as grade 3, but no serious adverse events were reported. The trial began in May. Read Full Article on Fierce Biotech >>
Moderna data supports use of omicron booster over original vaccine
November 14, 2022 / Moderna / Omicron Booster / FDA – A two-pronged COVID-19 booster shot developed by Moderna sparks a stronger immune response against omicron and its subvariants than the original vaccine, the company said Monday, supporting the federal government’s decision to authorize the shot before the data were accrued. In a press release, Moderna revealed the first results from human tests of the vaccine, now called mRNA-1273.222 and containing components that fight forms of omicron as well as the original coronavirus. The data show the level of virus-fighting antibodies generated by the new vaccine compared to the original, but not yet how well each shot protects against infection and disease. Read Full Article on Biopharma Dive >>
November 14, 2022 / Moderna / Omicron Booster / FDA – A two-pronged COVID-19 booster shot developed by Moderna sparks a stronger immune response against omicron and its subvariants than the original vaccine, the company said Monday, supporting the federal government’s decision to authorize the shot before the data were accrued. In a press release, Moderna revealed the first results from human tests of the vaccine, now called mRNA-1273.222 and containing components that fight forms of omicron as well as the original coronavirus. The data show the level of virus-fighting antibodies generated by the new vaccine compared to the original, but not yet how well each shot protects against infection and disease. Read Full Article on Biopharma Dive >>
PharmaJet inks deal to use needle-free delivery tech in polio vaccination campaign
November 15, 2022 / Polio / Vaccine / Pharma Jet / Needle-free Drug Delivery – PharmaJet has struck an agreement covering the use of its Tropis needle-free injection system in Nigeria, positioning vaccinators to deploy the technology in a project intended to tackle a poliovirus outbreak. Vaccination campaigns have dramatically reduced wild polio cases in recent decades, but, in areas with low levels of population immunity, the weakened live virus used in the oral polio vaccine can cause its own problems. After reverting to circulating vaccine-derived poliovirus (cVDPV), the live virus can cause paralysis. Last year, Nigeria reported 415 cases of type 2 cVDPV. Read Full Article on Fierce Pharma >>
November 15, 2022 / Polio / Vaccine / Pharma Jet / Needle-free Drug Delivery – PharmaJet has struck an agreement covering the use of its Tropis needle-free injection system in Nigeria, positioning vaccinators to deploy the technology in a project intended to tackle a poliovirus outbreak. Vaccination campaigns have dramatically reduced wild polio cases in recent decades, but, in areas with low levels of population immunity, the weakened live virus used in the oral polio vaccine can cause its own problems. After reverting to circulating vaccine-derived poliovirus (cVDPV), the live virus can cause paralysis. Last year, Nigeria reported 415 cases of type 2 cVDPV. Read Full Article on Fierce Pharma >>
Sellas retunes leukemia trial as patients live longer than expected. Is the biotech’s drug behind survival boost?
November 14, 2022 / SELLAS Life Sciences / Acute Myeloid Leukemia / Clinical Data – Patients are living longer than expected in Sellas Life Sciences’ phase 3 trial for an acute myeloid leukemia (AML) drug. That’s great news for patients and has spurred a protocol amendment for the study—but the question remains: Is it because of the biotech’s drug? The short answer is executives don’t know. The data have yet to be unblinded, and the analysis that led to the change in the main endpoint was pooled, meaning patients who received the treatment were lumped in with those in the control arm. Read Full Article on Fierce Biotech >>
November 14, 2022 / SELLAS Life Sciences / Acute Myeloid Leukemia / Clinical Data – Patients are living longer than expected in Sellas Life Sciences’ phase 3 trial for an acute myeloid leukemia (AML) drug. That’s great news for patients and has spurred a protocol amendment for the study—but the question remains: Is it because of the biotech’s drug? The short answer is executives don’t know. The data have yet to be unblinded, and the analysis that led to the change in the main endpoint was pooled, meaning patients who received the treatment were lumped in with those in the control arm. Read Full Article on Fierce Biotech >>
// Politics
A Democratic Senate improves the outlook for Biden health and science priorities, including key nominees
November 13, 2022 / Biden / Health and Science / Senate – With a Democratic Senate, as the Associated Press projected Saturday night, it will be much easier for President Biden to get nominees confirmed, including whomever he taps to lead the National Institutes of Health. Public health officials like National Institute of Allergy and Infectious Diseases Director Anthony Fauci will face less scrutiny, as Democrats will maintain power over key health committees. And Democrats will be a check on a possible Republican House that might want to clash with Biden over issues like government funding and Medicare. Read Full Article on STAT News>>
November 13, 2022 / Biden / Health and Science / Senate – With a Democratic Senate, as the Associated Press projected Saturday night, it will be much easier for President Biden to get nominees confirmed, including whomever he taps to lead the National Institutes of Health. Public health officials like National Institute of Allergy and Infectious Diseases Director Anthony Fauci will face less scrutiny, as Democrats will maintain power over key health committees. And Democrats will be a check on a possible Republican House that might want to clash with Biden over issues like government funding and Medicare. Read Full Article on STAT News>>
Biden would VETO proposed U.S. Senate resolution to end COVID national emergency
November 15, 2022 / White House / Biden / COVID / VETO – President Joe Biden would veto a proposed U.S. Senate resolution that would terminate a national emergency declared in 2020 in response to the COVID-19 pandemic, the White House said on Tuesday. Republican U.S. Senator Roger Marshall in September called for a vote to end the emergency declaration after Biden told CBS News in an interview that the pandemic was “over.” Read Full Article on Pharma Live >>
November 15, 2022 / White House / Biden / COVID / VETO – President Joe Biden would veto a proposed U.S. Senate resolution that would terminate a national emergency declared in 2020 in response to the COVID-19 pandemic, the White House said on Tuesday. Republican U.S. Senator Roger Marshall in September called for a vote to end the emergency declaration after Biden told CBS News in an interview that the pandemic was “over.” Read Full Article on Pharma Live >>
Biden to Federal Contractors: Make Plans to Cut Your Greenhouse Gas Emissions
November 16, 2022 / Biden / Greenhouse Gas / Paris Agreement- The Biden administration plans to require the largest federal contractors to set targets for slashing their greenhouse gas emissions in line with goals established under the Paris climate accord in 2015. The proposed rule, announced on Wednesday, could have wide repercussions throughout corporate America as the U.S. federal government is the world’s largest consumer of goods and services. Read Full Article on Nextgov >>
November 16, 2022 / Biden / Greenhouse Gas / Paris Agreement- The Biden administration plans to require the largest federal contractors to set targets for slashing their greenhouse gas emissions in line with goals established under the Paris climate accord in 2015. The proposed rule, announced on Wednesday, could have wide repercussions throughout corporate America as the U.S. federal government is the world’s largest consumer of goods and services. Read Full Article on Nextgov >>
Reassessing the Boundaries of Government
November 14, 2022 / Private Enterprise / US Government – Recent economic developments have reopened the debate on the government’s role in the affairs of private enterprises in market economies. European Union (EU) leaders have responded to elevated energy prices, caused by Russia’s invasion of Ukraine, with a plan to redistribute extraordinary profits from energy companies to poor households and vulnerable firms. Retail electricity prices in the EU have jumped by almost 50 percent on a year-on-year basis from July 2021 and are likely to hurt the poorest families which are bracing themselves for a difficult winter, on top facing elevated cost of living. The plan put forth by EU policymakers could redistribute as much as $136 billion. To fund it, the European Commission is advocating a tax of at least 33 percent on oil and gas companies. Furthermore, electricity companies that do not use gas but are earning windfall profits would face a levy, as the EU sets a threshold electricity price at less than half the current market rates. While how the EU plan would be implemented, is far from clear, what appears to be an isolated intervention event is becoming more frequent in a world of heightened political, economic, and social uncertainty. While multiple valid arguments have been made against increasing government interventions, we will maintain that such actions are both essential and beneficial, not only to civil society but also to the corporations in question. Read Full Article on California Review Management >>
November 14, 2022 / Private Enterprise / US Government – Recent economic developments have reopened the debate on the government’s role in the affairs of private enterprises in market economies. European Union (EU) leaders have responded to elevated energy prices, caused by Russia’s invasion of Ukraine, with a plan to redistribute extraordinary profits from energy companies to poor households and vulnerable firms. Retail electricity prices in the EU have jumped by almost 50 percent on a year-on-year basis from July 2021 and are likely to hurt the poorest families which are bracing themselves for a difficult winter, on top facing elevated cost of living. The plan put forth by EU policymakers could redistribute as much as $136 billion. To fund it, the European Commission is advocating a tax of at least 33 percent on oil and gas companies. Furthermore, electricity companies that do not use gas but are earning windfall profits would face a levy, as the EU sets a threshold electricity price at less than half the current market rates. While how the EU plan would be implemented, is far from clear, what appears to be an isolated intervention event is becoming more frequent in a world of heightened political, economic, and social uncertainty. While multiple valid arguments have been made against increasing government interventions, we will maintain that such actions are both essential and beneficial, not only to civil society but also to the corporations in question. Read Full Article on California Review Management >>
