// 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.
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.
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.
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.
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.
// 4th Industrial Revolution
A New Wearable Measures Brain Activity
November 11, 2022 / Brain / Wearable / New Health
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.
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.
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.
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.
LG Launches Virtual Care Solution with Amwell to Address Hospital Workforce Shortages
November 14, 2022 / Virtual Care / Hospital Workforce Shortage
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.
// 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.
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.
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.
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.
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.
// 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.
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.
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.
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.
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.
// 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.
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.
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.
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.
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.
// 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.
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.”
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.
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.