// Biotech and Pharma Therapeutics

Humira biosimilars arrive in the US, as Amgen launches first copycat to AbbVie’s blockbuster drug
January 31, 2023 / Humira / Amgen / AbbieVie / New Drug – Amgen’s drug, a so-called biosimilar named Amjevita, is the first of nine lookalike versions of Humira that are set to launch this year, which will help end Humira’s reign as one of the pharmaceutical industry’s most lucrative products. Worldwide sales totaled $20.7 billion in 2021 and another $15.7 billion over the first nine months of 2022. The bulk of those sales are in the U.S., following entry of biosimilar competitors in Europe four years ago. Read Full Article on Biopharma Dive >>
Novartis hasn’t given up on TIGIT, CEO insists, as Big Pharma ‘active’ in cancer M&A search
February 1, 2023 / Novartis / TIGIT / Immuno-oncology – Once seen as a bright hope for immuno-oncology, the reputation of anti-TIGIT checkpoint inhibitors has yet to recover from the double whammy of trial flops that Roche experienced last year. So you can perhaps forgive fellow Swiss drugmaker Novartis for not putting its own TIGIT ambitions front and center. Read Full Article on Fierce Biotech >>
GSK drops celiac program acquired in Sitari buyout—and delivers blow to bid to avert antibiotic apocalypse
February 1, 2023 / GSK / Celiac Disease / MRSA / Antibiotic-Resistant Bacteria – Sitari began life with the backing of GSK and Avalon Ventures, which were fresh from setting up a $495 million fund. The biotech raised a $10 million series A round and used the cash to build on what Stanford University’s Chaitan Khosla, Ph.D., had learned about TG2 inhibition. GSK bought Sitari in 2019 and took its lead candidate, GSK3915393, into the clinic the following year. Read Full Article on Fierce Biotech >>
Merck admits defeat in race with Valneva to get first chikungunya vaccine to market
February 2, 2023 / Merck & Co. / Valneva / Emergent BioSolutions / Tropical Diseases – Once neck and neck with Valneva to get the first chikungunya vaccine to market, it now looks like Merck & Co. has admitted defeat as its French rival reaches the finish line. Merck’s contender was V184, a vaccine acquired through the Big Pharma’s $366 million takeover of Themis in 2020. While the candidate completed a phase 2 trial, the study was suspended “due to a clinical stock recovery action” from December 2020 to the completion date in June 2021— meaning it never hit its original enrollment goal. Read Full Article on Fierce Biotech >>
Amid mainstream hype, Eli Lilly takes a hard line marketing its buzzy diabetes med Mounjaro
February 2, 2023 / Eli Lilly / Mounjaro / Anat Ashkenazi / CFO – After Lilly’s rival Novo Nordisk faced overwhelming demand in 2022 for Type 2 diabetes blockbuster Ozempic, Lilly is keeping a close watch on Mounjaro production capacity, plus the ways in which patients are using the medication. Specifically, the company wants to clamp down on potential off-label use in patients who don’t have diabetes. Read Full Article on Fierce Pharma >>

// 4th Industrial Revolution

Microsoft signs first AI healthcare partnership in Vietnam
January 31, 2022 / Microsoft / AI / Healthcare / Vietnam – According to a press release, the partnership, which is a first for the global tech company in Vietnam, will work on three areas of AI healthcare: data sharing, cross-product validation, and R&D. VinBrain will leverage DrAid, its suite of AI-powered pathology solutions which can detect 21 disease indicators of the heart, lungs and bone. The US FDA-approved platform is being used by around 2,000 doctors and more than 100 hospitals in Vietnam. Read Full Article on Healthcare IT News >>
Lunit’s AI boosts Guardant Health’s cancer detection capability
January 31, 2023 / Lunit / AI / Cancer Detection / New Teck – The Lunit SCOPE PD-L1 does AI-based quantification of tissue samples using a scoring system. Integrating it with the Guardant test will enhance biomarker assessment for NSCLC patients, the company claimed in a press statement. The AI has helped lift the test’s detection of PD-L1 by over 20% compared to manual pathologist interpretation. Read Full Article on Mobi Health News >>
GoodRx shared health data with Google and Facebook, FTC says
February 1, 2023 / GoodRx / Fine / Health Data – GoodRx agreed to pay a $1.5 million fine to settle the case, but admitted no wrongdoing. In addition to the payment, the FTC said its proposed court order would permanently prohibit GoodRx from sharing health data for ads, require user consent before sharing information with third parties for other purposes, direct third parties to delete previously shared data, limit how long GoodRx can keep patient information and force the company to put a privacy protection plan in place. Read Full Article on Mobi Health News >>
Mark Cuban Cost Plus Drug Company partners with digital cancer care tool
January 31, 2023 / Mark Cuban / Cost Plus / Drug Price / Digital Cancer Care – Mark Cuban Cost Plus Drug Company (MCCPDC) is partnering with cancer care support company OncoPower to offer prescription drugs at a decreased cost via a platform dubbed Medication Savings Suite. The suite will be integrated within OncoPower’s Pill Reminder Tool, which will alert patients of cheaper generic medication options available through MCCPDC when patients log a new medication into the tool. Read Full Article on Mobi Health News >>
NYU develops health metrics dashboard for all 435 U.S. Congressional Districts
February 1, 2023 / NYU / Health Metrics Dashboard / U.S. Congressional Districts / Policymakers – Incorporating health measures, such as deaths from cardiovascular disease and breast cancer, along with conditions that affect health, like housing affordability and access to nutritious foods, has not been available at the congressional district level. Offering a single publicly-accessible location, the Congressional District Health Dashboard was built to offer a comprehensive data view of persistent inequities across the country, according to Dr. Giridhar Mallya, senior policy officer at the Robert Wood Johnson Foundation, a partner on the project. Read Full Article on Healthcare IT News >>

// Business & Markets

Lilly reports fast sales for new diabetes drug
February 2, 2023 / Eli Lilly / New Drugs / Diabetes / Sales – Fourth quarter sales totaled $279 million, bringing the total for 2022 to $483 million following the drug’s June launch. The fast sales put Mounjaro, approved to improve blood sugar control in people with Type 2 diabetes, on pace to quickly reach blockbuster status. Studies have shown the drug to have a powerful weight-loss effect as well, supporting Lilly’s current efforts to expand the drug’s approval to include obesity treatment. Read Full Article on Biopharma Dive >>
Opioid Use Disorders Cost U.S. Hospitals More than $95B Annually
February 1, 2023 / Opioid / Hospital Costs – In addition to the enormous economic, physical and emotional toll on individuals, families and society, data from PINC AI™ Applied Sciences (PAS) shows that care for patients with opioid use disorders (OUDs) in the hospital setting resulted in billions in annual hospital costs nationwide – the majority of which were not reimbursable or were paid for by public payers.Read Full Article on Hit Consultant >>
Novartis CEO, as incoming PhRMA chair, outlines 3 priorities for pharma after IRA setback
February 2, 2023 / Novartis / Vasant Narasimhan / PhRMA / Drug Prices- Passed last year, the IRA will allow the government to negotiate prices on the costliest drugs in Medicare starting in 2026. It also forces companies to pay rebates if they raise Medicare drug prices faster than the rate of inflation, and it sets an out-of-pocket cap for patients in Medicare, among other changes. To Narasimhan, there are three “core priorities” that the biopharma industry should target while the law is still being rolled out. Read Full Article on Fierce Pharma >>
Insurers Slam CMS for Medicare Advantage RADV Final Rule
Jaunary 31, 2023 / CMS / Medicare / RADV – Insurers are pushing back after the Centers for Medicare & Medicaid Services (CMS) on Monday issued its final rule on the Medicare Advantage Risk Adjustment Data Validation (RADV) program. The rule will lead to stricter audits on Medicare Advantage plans. Read Full Article on Med City News >>
Layoffs continue to batter biotech, with Big Pharmas piling on the pain
February 1, 2023 / Layoffs / Merck KGaA / Amgen / TCR2 Therapeutics – More companies laid off staff last month than in January 2022, driven by trims at billion-dollar Big Pharmas and smaller biotechs that had to downsize for the second time in less than a year. Over the last four weeks, at least 13 different companies have announced staff reductions, resulting in hundreds of layoffs and maintaining pessimism that the industry as a whole has yet to find the floor. That exceeds the eight companies that had layoffs in January 2022 and ties the fourth-highest month of layoffs recorded in the last 13 months.Read Full Article on Fierce Biotech >>

// Legal & Regulatory

FDA approves cancer drugs from Lilly, Menarini
January 30, 2023 / FDA / Eli Lilly / Menarini / Cancer Drugs – Lilly’s and Menarini’s treatments are notable in their own right, too. Lilly’s drug, which will be sold as Jaypirca, is the fourth drug of its type, targeting a protein known as Bruton’s tyrosine kinase to treat relapsed or refractory mantle cell lymphoma. But it works differently than the three cleared before it, binding to that protein reversibly rather than irreversibly. It’s cleared for use after other BTK inhibitors and, according to Lilly, could help patients in whom those other drugs no longer work. Read Full Article on Biopharma Dive >>
Moderna Granted FDA Breakthrough Therapy Designation for mRNA-1345, An Investigational Respiratory Syncytial Virus (RSV) Vaccine Candidate
January 30, 2023 / Moderna / FDA / Vaccine – “The FDA’s Breakthrough Designation for mRNA-1345 further emphasizes the significant health impact of RSV in older adults and the high unmet need,” said Stéphane Bancel, Chief Executive Officer of Moderna. “With this designation, we look forward to productive conversations with the FDA in the hopes of bringing our RSV vaccine candidate for older adults to the market safely and quickly. Moderna’s mRNA platform has now demonstrated two positive Phase 3 infectious disease trial results and we continue to advance a portfolio of respiratory mRNA vaccines targeting the most serious diseases. We are grateful to the FDA for this designation.” Read Full Article on Biospace >>
FDA Asks Gene Therapy Biotech to Run Clinical Trial That Might Be Impossible
February 1, 2023 / FDA / Gene Therapy / Biotech / Trials – One challenge of developing a drug for a disease with no approved therapies is that there isn’t an established clinical trial roadmap to follow. Taysha Gene Therapies hoped the trial design for its gene therapy for a rare neuromuscular disease would put it on the path to a regulatory submission. FDA questions about the study mean that the path forward is almost certainly longer, and might not even be possible. Read on Med City News >>
Court rejects Johnson & Johnson’s Texas two-step bankruptcy ploy for talc claims
January 30, 2023 / Johnson & Johnson / Talc Litigation / Bankruptcy / 3M – The ruling, from the Third U.S. Circuit Court of Appeals, prevents J&J from funneling approximately 40,000 lawsuits into its newly created subsidiary, LTL Management LLC, and declaring it bankrupt, a ploy that could save the company billions. Read on Fierce Pharma >>
In mysterious FDA approval, Pfizer quietly wins Ibrance breast cancer expansion
January 31, 2023 / Pfizer / U.S. FDA / Ibrance / Breast Cancer –The FDA has extended Ibrance’s approval in combination with an aromatase inhibitor to include newly diagnosed HR-positive, HER2-negative metastatic breast cancer patients regardless of menopausal status, Pfizer said Tuesday. Read on Fierce Pharma >>

// Research & Development

Lilly drops 2nd program against NASH target that caught Pfizer’s eye
February 2, 2023 / Eli Lilly / Pfizer / NASH / Nonalcoholic Steatohepatitis – Eli Lilly’s second stab at developing a KHK inhibitor in diabetes and nonalcoholic steatohepatitis (NASH) is over. Fifteen months after dropping its first candidate, Lilly has kicked the second program from its phase 1 pipeline, dealing another blow to a target that has attracted the attention of Pfizer. Read Full Article on Fierce Biotech >>
Novartis cans branaplam after seeing Huntington’s safety signal, delays orphan drug over slow enrollment
February 1, 2023 / Novartis / Hntington’s Disease / Rare Diseases / Pipeline –
Novartis has delivered the coup de grâce to its ailing branaplam program, stopping (PDF) development of the splicing modulator in Huntington’s disease in the wake of a safety signal. The Big Pharma disclosed the update alongside news of the delays and discontinuations that have hit oral factor B inhibitor iptacopan.Read Full Article on Fierce Biotech >>
Lilly execs shrug off Alzheimer’s rejection while assuring investors safety was not an issue
February 2, 2023 / Eli Lilly / Donanemab / Alzheimer’s Disease / FDA – As analysts pressed for additional details about what the FDA is worried about, Lilly’s execs were clear that safety was not in question. One specific concern among analysts is a known complication in the treatment class called amyloid-related imaging abnormalities, or ARIA, which are abnormalities that show up in MRI imaging and can signal bleeding in the brain or swelling. Chief competitor Eisai has been dogged by ARIA issues for its latest Alzheimer’s offering lecanemab, which has beaten donanemab to the market via an accelerated approval granted in early January. Read Full Article on Fierce Biotech >>
Following in Lilly’s footsteps, Teva takes 2nd long-acting schizophrenia drug into phase 3
January 31, 2023 / Eli Lilly / Teva Pharmaceuticals / MedinCell / Schizophrenia Drug – The candidate is the latest product of Teva’s collaboration with MedinCell, the French developer of BEPO technology for extending the release of injectable therapies. Using the technology, MedinCell formulates active ingredients so they turn into a depot after administration. The depot breaks down over time and therefore provides the patient with several weeks’ worth of the drug from a single dose. Read Full Article on Fierce Pharma >>
Novartis confirms it has stopped development of experimental Huntington’s drug
February 1, 2023 / Novartis / Huntington’s Drug / Advanced Clinical Testing – The reason, according to Novartis, was an “overall assessment of the risk-benefit profile” observed in a mid-stage clinical trial named VIBRANT-HD. In August, Novartis said it had temporarily suspended dosing in the study, after discovering that some patients treated with the drug, known as branaplam, were experiencing nerve damage. Read Full Article on Biopharma Dive >>

// Politics

House bill would put a stop to VA EHR modernization
February 1, 2023 / House of Rep / New Bill / VA EHR Modernization – As he enters his second term serving the House Veterans Affairs Committee, Rosendale will now chair the Subcommittee on Technology Modernization legislative, which oversees and has investigative jurisdiction over the VA’s enterprise technology modernization programs and projects. Read Full Article on Healthcare IT News >>
Biden Officials Pressed on Mexico Corn Trade Issue at Farm Bill Hearing
February 2, 2023 / Biden Office / Mexico / Corn Trade / Farm Bill – “When it comes to agricultural trade, the concern I hear most from Iowans is access to Mexico’s corn market,” said Sen. Chuck Grassley (R-Iowa). “With over 90% of the corn acreage in the United States being planted to biotech seeds and Mexico being the number one purchaser of U.S. corn, I’m concerned that this decree is not being met with the urgency that it deserves,” he said, referring to Mexican President Andrés Manuel López Obrador’s decree that would phase out imports of GMO corn in 2024 — extended to 2025 under a compromise López Obrador’s administration recently offered, but which the U.S. rejected. Read Full Article on Ag Web Farm Journal >>
Washington Week Ahead: FDA set to respond to demands for overhaul
January 29, 2023 / FDA / Washington / Senators / Farm Bill – FDA Commissioner Robert Califf is due to announce this week what steps he’ll to take to tighten leadership of the agency’s food programs, while the Senate Agriculture Committee resumes its hearings on the next farm bill, and corn growers try to raise awareness of Mexico’s looming ban on biotech corn. Read Full Article on Agri Pulse >>
Opinion: Pharmacists are health care providers, not political actors
January 29, 2023 / Health care / Politics / Pharmacist – Pharmacy Benefit Managers, or PBMs, provide your prescription coverage. Part of that is negotiating with drug manufacturers to get you lower prices on medicine. Many also provide a range of other services to make it simpler — and more affordable — to get the medicine people need. Read Full Article on Austin American-Statesman >>
Attacking Our Leading Tech Innovators for Political Gain Comes at Our Own Peril
January 31, 2023 / Tech Innovators / Politics / Tech Companies / Biden – The tension over the tech advantage was obvious as President Joe Biden made clear that the United States would “continue to compete vigorously,” while China pushed back on restrictions imposed last month by the US on China’s access to semiconductor technology that can be used to deliver hypersonic missiles or potentially crack the US military’s most advanced codes. Read Full Article on The Defense Post >>