// Biotech and Pharma Therapeutics

Early data hint at benefit for Amgen’s obesity drug
 November 8, 2022 / Amgen / Obesity Drug / Early Data / Weight Loss –An experimental drug from Amgen helped people who are obese lose up to 15% of their body weight in a short study, a finding that has prompted executives to accelerate its development, the company said Monday. The data, revealed at a medical meeting on Monday, come from a small Phase 1 trial primarily designed to test safety and find the best dose of the drug to move into further testing. Amgen has only provided summary results. Full details will be presented at a conference next month. Read Full Article on Biopharma Dive>>
Viatris to buy two eye drug developers in deals worth up to $750M
 November 7, 2022 / Viatris / Eye Drug – Viatris was created through a 2019 merger between Pfizer’s generic drug unit, Upjohn, and the struggling generics maker Mylan. It has been working since to stabilize a declining business and position itself for growth in the future. Like other generic drugmakers, the company has taken to restructuring and consolidation. In February, for example, Viatris sold its biosimilars business to partner Biocon for up to $3.3 billion in an effort to raise cash. Read Full Article on Biopharma Dive>>
Pfizer, BioNTech data support new Covid booster’s advantage over original vaccine
 November 4, 2022 / Pfizer / BioNTech / New Covid Booster –Pfizer and BioNTech’s updated booster was quickly made ready in time for a campaign by the Biden administration to encourage vaccination before the flu and winter season. The Food and Drug Administration’s authorization came based on limited preclinical data, as well as trial results from a similar, but different reformulation of the companies’ original shot. Pfizer and BioNTech initially shared seven-day immune response data in mid-October, but they did not reveal specific data. Read Full Article on Biopharma Dive >>
Biotechs put assets up for sale and on the shelf in quarterly pipeline clear-outs
 November 9, 2022 / Arbutus Biopharma / Xilio Therapeutics / Protagonist Therapeutics / Aptinyx –Biotech earnings season has delivered a deck of dead and deprioritized assets, with Xilio Therapeutics, Protagonist Therapeutics, Arbutus Biopharma and Aptinyx all deciding they have better uses for their cash. Xilio posted preliminary pharmacokinetic data from a phase 1 trial of its tumor-activated anti-CTLA-4 candidate XTX101 over the summer, leading it to outline plans to explore a phase 2 study in colorectal cancer. Months later, and with initial results from the trial still on the horizon, the biotech has decided to wind down its investment in the candidate. Read Full Article on Fierce Biotech >>
CEOs of BioNTech, Bayer, Merck KGaA join German Chancellor Scholz in high-profile China visit
 November 4, 2022 / China / BioNTech / Bayer / Merck KGaA –In the first visit by a G7 leader to China since the pandemic started, German Chancellor Olaf Scholz has led a business delegation to the country. CEOs of biopharma titans Bayer, BioNTech and Merck KGaA are among the 12-person team of industry leaders to make the trip. Bayer’s Werner Baumann, BioNTech’s Ugur Sahin and Merck KGaA’s Belén Garijo joined Scholz on the one-day visit Friday. No major investment deals have come out of the high-profile trip. Read Full Article on Fierce Pharma>>
With new data in hand, Amgen plans to take heart drug into phase 3 to challenge Novartis
 November 7, 2022 / Amgen / Cardiovascular / Clinical Data / Novartis –With fleshed-out phase 2 data, Amgen is now ready to launch a late-stage trial of its heart drug by the end of this year. The Big Pharma currently lags behind Novartis, which has already launched a fully-enrolled phase 3 in the niche cardiovascular space, though Amgen’s new data may give it a leg up on the Swiss drugmaker. The end-of-treatment data comes from Amgen’s phase 2 study of olpasiran, an interfering RNA treatment previously known as AMG 890. This summer, the company shared limited data from the trial, dubbed OCEAN(a)-DOSE, which found the therapy reduced levels of lipoprotein, or Lp(a)—a risk factor for cardiovascular disease. Research suggests that high levels of Lp(a) can contribute to stroke, peripheral arterial disease and heart attack. Read Full Article on Fierce Biotech>>
Life beyond COVID: BioNTech lines up 5 infectious disease vaccine trials for 2023
 November 7, 2022 / BioNTech / mRNA / Tuberculosis / Cancer Vaccine –The German-based biotech has a list of first-in-human trials for mRNA vaccines ready to go in the coming months, including BNT163 for herpes simplex virus type 2 (HSV-2). A vaccine for shingles is also expected this year, in collaboration with long-term partner Pfizer, and is likely to be followed by a malaria vaccine dubbed BNT165, which will enter trial participants’ arms either this year or in early 2023. The opening months of 2023 should also see the first patient receive BNT164, a vaccine for tuberculosis, the company said in its third-quarter earnings results. The accelerating infectious disease pipeline update comes a week after BioNTech began a phase 1 trial of an mRNA-based combination vaccine for influenza and COVID-19. Read Full Article on Fierce Biotech>>

// 4th Industrial Revolution

Australian Teletrial Program to expand nationwide with $45M funding
November 8, 2022 / Australia / Teletrial Program / Telehealth –A national programme that seeks to expand the reach of clinical trials across Australia will continue to be implemented over the next four years with A$75 million ($45 million) investment from the Commonwealth Medical Research Future Fund. The Australian Teletrial Program (ATP), which was first piloted in 2018, leverages telehealth technology to create a network of rural, regional and remote clinical trial sites nationwide. It allows clinicians and participants to take part in clinical trials remotely so they will no longer have to travel long distances to major cities. Read Full Article Healthcare IT News>>
Mayo Clinic expands AI-driven biomarker diagnostics partnership
November 4, 2022 / AI / Mayo Clinic / Numares – Using algorithms to analyze multiple biomarkers to measure disease progression in patients can help physicians improve care for those with chronic diseases, including kidney and cardiovascular conditions. Over nearly two decades, the Woodlands, Texas, and Regensburg, Germany-based company has developed diagnostic tests applying artificial intelligence and advanced nuclear magnetic resonance (NMR) spectroscopy. Full Article on Healthcare IT News >>
Orlando Health to launch Hospital Care at Home program
November 8, 2022 / Florida / Home Treatment –The health system is planning to launch its Hospital Care at Home initiative in February and make it available to specific patients who meet certain clinical criteria determined by emergency department and hospital staff. Conditions such as cellulitis, COPD, asthma, UTI, heart failure, COVID-19, pneumonia and gastroenteritis are among those that can be treated safely in a home-based program. Orlando Health’s program is the first in Central Florida to be approved by the Centers for Medicare and Medicaid Services and represents an expansion of a federal enhanced care model created during the pandemic to extend the scope of hospital resources. Read Article on Healthcare IT News >>
Plastics reborn: Inside Novo Nordisk’s prefilled pen recycling pilot
November 9, 2022 / Novo Nordisk / Environmental, Social and Governance / Sustainability / Recycling – It’s an increasingly common fate for the company’s used injection devices under Novo’s fledgling PenCycle program. After making its debut in Denmark, the prefilled pen recycling pilot has expanded to Brazil and recently also launched in the U.K., Katrine DiBona, Novo Nordisk’s corporate vice president of global public affairs and sustainability, said in a recent interview. Read Full Article on Fierce Pharma >>
Plotting a Fulgent future, diagnostic business inks $100M deal to reunite with drug delivery sibling
November 8, 2022 / Drug Delivery / Drug Solubility / Drug Delivery Nanoparticle / M&A –The two businesses collectively made up Fulgent Therapeutics from 2011 to 2016. At the end of that period, the businesses split, enabling Fulgent Genetics to go public and leaving the pharma unit as a standalone private company. Since then, Fulgent Pharma has published clinical data on a candidate that uses its nano-encapsulation technology to overcome the limitations of paclitaxel. After seeing sales soar, then fall, on the back of COVID-19 testing demand during the pandemic, Fulgent Genetics has decided to reconnect with its sibling. The deal sees the diagnostic company pay $43.4 million in cash, plus $30.7 million in its common stock, to acquire the pharma business.Read Full Article on Fierce Pharma >>
Rural NY health system working with Silicon Valley to expand access, digital transformation
November 9, 2022 / New York / Digital Transformation / Silicon Valley / Partnership –The partnership aims to advance the patient experience, assure financial sustainability and position Bassett Healthcare for long-term growth. The health network will leverage healthcare technologies that a16z Bio + Health has backed financially, as well as innovations in enterprise tech, consumer services and other relevant fields. The firm will also work with Bassett Healthcare to identify emerging areas of unmet need in the network that could benefit from technology-enabled solutions. “Health systems serving rural communities face challenges distinct from those in more densely populated areas, including less access to innovative tools and services that could help us better serve our patients and support our practitioners and care teams,” Dr. Tommy Ibrahim, president and CEO of Bassett Healthcare Network, said in the announcement. Read Full Article on Healthcare IT News >>

// Business & Markets

Amid ‘biotech winter,’ Insilico turns up the heat with Sanofi deal worth $1.2B in biobucks
November 8, 2022 / Insilico Medicine / Sanofi / Biotech Deals / Drug Discovery –Insilico Medicine is radiating heat amid the biotech winter, kindling its fires with a Sanofi collaboration that could be worth up to $1.2 billion in biobucks—the AI drug discovery company’s largest deal to date. “It’s the golden time for Insilico,” CEO Alex Zhavoronkov, Ph.D., told Fierce Biotech. The pact validates the Hong Kong-based company’s platform and methods, particularly against the backdrop of the ongoing “biotech winter,” the CEO said. Read Full Article on Fierce Biotech>>
Arrowhead fills quiver with $250M Royalty deal for Amgen-partnered crown jewel
November 9, 2022 / Amgen / Arrowhead Pharma / Royalty Pharma / Royalties –Merck & Co. is bidding adieu to the oncolytic virus acquired from its 2018 purchase of Viralytics, with the pipeline change disclosed weeks after the Big Pharma hitched its wagon onto Moderna’s cancer vaccine program. Read Full Article on Fierce Biotech >>
Biohaven fuels up for post-Pfizer future with $302M fundraising, fresh faces in the C-suite
November 8, 2022 / Biohaven Pharma / Pfizer / Epilepsy / Central Nervous System – A new, slimmed-down Biohaven issued its debut earnings release post-Pfizer split, touting a $301.9 million fundraising, new executive staffers and a pipeline stocked with therapies to test in epilepsy and neuropsychiatric conditions. Biohaven Ltd., formerly known as Biohaven Pharmaceutical Holding Company Ltd., officially launched Oct. 4 after the $11.6 billion acquisition deal with Pfizer closed. That deal saw its migraine franchise calved off to join the pharma giant, while Biohaven retained its pipeline. Read Full Article on Fierce Biotech >>
Pharma earnings outline drug law’s looming impact on sales, development
November 9, 2022 / Drug Law / Sales / Development / Pharma Earnings – Biotechnology and pharmaceutical companies are still parsing the U.S. drug pricing law enacted in August, but recently have begun to warn investors of looming impacts to their development plans and to future sales. In regulatory filings and earnings calls over the past few weeks, major drugmakers described significant uncertainty over how the law will be implemented and how it might directly affect their business. But some have been more specific, with Merck & Co. and Amgen noting they expect it to impact future sales. And a few, including Eli Lilly, Alnylam Pharmaceuticals and Alkermes, have cited the law specifically in decisions to cut back or reshape their drug research.Read Full Article on Biopharma Dive >>
Zenas zips up $118M to launch phase 3 for rare autoimmune disease candidate
November 8, 2022 / Xencor / Zenas BioPharma / Autoimmune Disease / Series B – Zenas BioPharma has raised a $118 million series B to zoom in on a pipeline of immune-based therapies and launch a phase 3 for its lead candidate that was licensed from Xencor less than a year ago. The Massachusetts biotech will use the equity financing to start a global phase 3 trial by the end of this year for lead candidate obexelimab. The bispecific antibody is being assessed in patients with IgG4-related disease, a chronic fibroinflammatory disease that can affect multiple organs and sites. Read Full Article on Fierce Biotech >>

// Legal & Regulatory

Yes, no, maybe: FDA panel delivers mixed verdict on AstraZeneca’s asthma rescue medication
November 9, 2022 / AstraZeneca / FDA / Asthma / FDA Advisory Committee –AstraZeneca has taken a step toward winning approval of its asthma rescue medication PT027 in adults after a FDA advisory committee voted overwhelmingly that its benefits outweigh the risks. But the panel delivered a split decision on adolescent use and voted against approval in children. T027, a fixed-dose combination of albuterol and budesonide, breezed through part of the meeting as the panelists voted 16 to one that the data support a favorable benefit-risk assessment of use of the drug as a rescue medication in adults. The panelists noted the “strong” efficacy data and lack of safety signals. Randi Oster, the acting consumer representative and the co-founder and president of Help Me Health, was the only member of the panel to vote no.Read on Fierce Biotech >>
Arrowhead capitalizes on Amgen drug progress with royalty rights deal
November 9, 2022 / Arrowhead / Amgen / Royalty Rights Deal – Arrowhead Pharmaceuticals is capitalizing on the clinical trial success of a drug it licensed to Amgen six years ago, announcing Wednesday a royalty rights deal that will hand it $250 million now and as much as $160 million more over time. Under the agreement, Arrowhead will sell rights to future royalties on an experimental heart disease drug called olpasiran to Royalty Pharma, a prolific biopharmaceutical dealmaker. Arrowhead’s royalty interest in olpasiran, which Amgen plans to advance into late-stage clinical testing this year, goes up to low double digits on future net sales worldwide. Arrowhead will still be eligible to receive milestone payments from Amgen on olpasiran’s development, regulatory and sales success, potentially worth up to $400 million. Read on Biopharma Dive >>
BioMarin signals lengthier FDA review for hemophilia gene therapy
October 27, 2022 / BioMarian / FDA / Hemophilia Gene Therapy –The Food and Drug Administration may need an additional three months to review BioMarin Pharmaceutical’s experimental gene therapy for severe hemophilia, potentially adding another delay in the biotechnology company’s long road to a decision on the treatment’s approval. The regulator wants to look over three-year follow-up results from BioMarin’s principal clinical trial, the company said Monday evening. The additional data might constitute what the FDA terms a “major amendment” to the drug’s application and necessitate a review extension. Read on Biopharma Dive >>
BioMarin’s hemophilia gene therapy may face further delays over fresh FDA requests
November 8, 2022 / BioMarin Pharma / Hemophilia / Cell & Gene Therapy / FDA – Despite getting the green light in Europe this summer, BioMarin’s hopes for bringing its hemophilia gene therapy to the U.S. remain as distant as ever, with the FDA now requesting a look at its manufacturing site and long-term phase 3 data. Back in May, the company revealed that the FDA had asked additional questions about the one-and-done therapy, called valoctocogene roxaparvovec or Roctavian, pushing back an anticipated approval decision date to September. BioMarin resubmitted its application last month, prompting the agency to request an inspection of the company’s gene therapy manufacturing facility in Novato, California, as well as an upcoming three-year data analysis from the phase 3 GENEr8-1 trial. Read on Fierce Biotech >>
FDA halts Verve plans to test gene editing therapy for heart disease in US
November 7, 2022 / FDA / Gene Editing Therapy / Heart Disease – The Food and Drug Administration has halted plans by Verve Therapeutics to test a new gene editing treatment for heart disease in a Phase 1 trial in the U.S. Alongside its quarterly earnings statement on Monday, Verve said the Food and Drug Administration placed a clinical hold on the treatment, VERVE-101, disrupting its plans to begin the trial in the U.S. Verve didn’t say what triggered the FDA’s decision. It submitted data to regulators in October and expects to receive an official letter with the FDA’s questions within a month. The company said it will work with the agency to resolve the hold “as promptly as possible.” Read on Biopharma Dive >>
Regeneron wins broader US use of cancer immunotherapy
Novemeber 9, 2022 / Regeneron / Cancer Immunotherapy / FDA –Regeneron is counting on expanding Libtayo’s market after buying out full rights to the drug from its former partner, Sanofi. As part of the deal, Regeneron agreed to pay the French drugmaker $900 million plus royalties and as much as $200 million in additional fees. Libtayo has a lot ground to make up, however. Its initial approval came in 2018, well after top-selling competitors such as Merck & Co.’s Keytruda and its sales have remained comparatively low. Total sales reached $143 million in the third quarter, compared with $5.4 billion for Keytruda and almost $2.1 billion for Bristol Myers Squibb’s Opdivo. Read on Biopharma Dive >>

// Research & Development

Arrowhead Gets $250M in Royalty Deal for Cardio Drug Heading to Phase 3
November 9, 2022 / Arrowhead / Royalty Deal / Cardio Drug / Phase 3 – Arrowhead Pharmaceuticals is turning its financial tie to a promising but still experimental heart drug into $250 million in immediate cash, a move that comes days after the reporting of Phase 2 data showing the therapy successfully reduced levels of a protein associated with the risk of cardiovascular disease. The data for the drug, olpasiran, were reported by Amgen, which licensed the RNA therapy from Arrowhead. That deal grants Pasadena, California-based Arrowhead royalties from Amgen’s sales of the drug, if it reaches the market. That market is a big one as heart disease remains a leading cause of death, positioning oplasiran as a potential blockbuster seller. Read Full Article on MedCity News >>
GSK hep B treatment’s efficacy slips 60% in full phase 2 readout, but phase 3 going ahead
November 8, 2022 / GSK / Chronic Hepatitis B – The efficacy of GSK’s hepatitis B treatment may have dropped by over 60% between the interim and end-of-study analysis, but the Big Pharma is still hopeful the antisense oligonucleotide treatment will provide a functional cure for the infection. The end-of-study results from the B-Clear phase 2b trial showed that 9% of patients with chronic hepatitis B on stable nucleoside/nucleotide analogues (NA) treatment and 10% of those not on NA treatment achieved the study’s primary outcome of a sustained clearance of their hepatitis B surface antigen levels and hepatitis B virus (HBV) DNA levels. Patients received 24 weeks of treatment with a 300 mg weekly dose. Read Full Article on Fierce Biotech>>
GSK myeloma drug comes up short in confirmatory test
November 7, 2022 / GSK Mveloma Drug / Blood Cancer – A blood cancer drug from GSK failed to outperform standard treatment in a Phase 3 clinical trial, disrupting the British drugmaker’s plans to confirm its medicine’s conditional approval with follow-up evidence of its benefit. In a study of 325 adults with relapsed or refractory multiple myeloma, GSK’s drug, called Blenrep, did not extend progression-free survival by significantly more than a treatment regimen consisting of Bristol Myers Squibb’s Pomalyst and the steroid dexamethasone. Read Full Article on Biopharma Dive>>
Ipsen drug shows benefit in pancreatic cancer, lifting shares of ghost company
November 9, 2022 / Ipsen Drug / Pancreatic Cancer / Merrimack – A regimen involving the pancreatic cancer treatment Onivyde and chemotherapy helped extend the lives of newly diagnosed patients with metastatic disease, a finding that boosts the drug’s owner, Ipsen, as well as the shell of the biotechnology company that originally developed the treatment. In a statement on Wednesday, Ipsen said, without details, that the Onivyde-chemo combination helped patients with pancreatic ductal adenocarcinoma live longer than those who received a different chemo regimen in a Phase 3 trial. Ipsen didn’t provide specifics, including the drug’s effect size, but said that details will be presented at a future medical meeting. Read Full Article on Biopharma Dive >>
Time runs out for Kronos’ phase 3 AML drug as biotech blames enrollment struggles for ending trial
November 9, 2022 / Kronos Bio / Acute Myeloid Leukemia / Solid Tumor / Contract Research Organization – While the biotech bear market has forced many companies to trim their pipelines, it’s less common to see a late-stage asset thrown on the scrapheap. But Kronos Bio has made that call for its acute myeloid leukemia (AML) drug entospletinib. The biotech will discontinue the phase 3 trial of its spleen tyrosine kinase (SYK) inhibitor entospletinib for the treatment of newly diagnosed patients with NPM1-mutated AML. The company stressed the decision had been made due to enrollment difficulties rather than reports of any adverse events or lack of efficacy. Read Full Article on Fierce Biotech >>

// Politics

Big Pharma CEOs Discuss Collaboration, Talent And IRA Implications At Galien Forum
November 9, 2022 / Collaboration / IRA Implications / Galien Forum / COVID Therapies – The second half of the Galien Forum on October 27 convened a panel on reframing the biopharma business model, as well as a panel on the current state of COVID-19 therapies and a future outlook. Panelists from both sessions pointed to a need for education and additional focus on building trust in the healthcare system. According to Edelman’s Trust Barometer survey data, published in March 2022, 52% of respondents said the COVID pandemic decreased their confidence that the healthcare system is well-equipped to handle major health crises. Fifty-five percent of Edelman’s 10,000 respondents expressed worry about medical science becoming politicized or being used to support a specific political agenda. Read Full Article on Life Science Leader >>
BioStock: DanCann Pharma rides the cannabis legalisation wave
November 4, 2022 / BioStock / Cannabis Legalisation / DanCann – We are seeing a shift in the political will to decriminalise cannabis, not least in the US and Germany, where significant steps in legislature are being considered. This will also have important effects on the field of medical cannabis, which has already seen a tectonic shift towards a more general acceptance in recent years. Danish biopharma company DanCann Pharma, with one of the world’s most modern facilities for manufacturing medical cannabis, is one of the top European players in this field. To inch closer to profitability, the company is now carrying out a rights issue of 28.5 million DKK that ends on November 11th. Read Full Article on Market Screener >>
Investors face unclear outcome in midterms, with questions over spending, regulation
November 9, 2022 / Midterm Elections / Investors / Politics – Investors on Wednesday were weighing a surprising outcome in the U.S. midterm elections, as a better-than-expected showing by Democrats muddies the outlook for issues such as fiscal spending and regulation. Control of Congress, which is currently held by President Joe Biden’s Democratic party, remained up for grabs early on Wednesday with many of the most competitive races yet to be called. Republicans were still expected to make gains and likely win control of the House of Representatives. But prospects of a “red wave,” which had picked up steam heading into Tuesday’s vote, had evaporated and the balance of power in the Senate remained unclear. Read Full Article on Reuters >>
Political Gridlock Would Bring Big Pharma a Sigh of Relief
November 7, 2022 / Gridlock / Drug Pricing – That might be bad from a policy-making standpoint, but you won’t hear too much complaining from drugmakers and their investors. Earlier this year they suffered a rare legislative defeat at the hands of a Democratic-controlled Congress. With Republicans widely expected to flip the House of Representatives, and possibly the Senate, congressional action is likely to be very limited until at least 2024. That probably means no further steps against pharma and biotech companies beyond the Inflation Reduction Act, which passed without a single Republican vote earlier this year. Republican control of one or both chambers of Congress would also give the drug industry potential allies in its effort to weaken the law. Read Full Article on Wall Street Journal >>