// Biotech and Pharma Therapeutics

Tubulis and BMS Team Up to Develop Antibody-Drug Conjugates for Cancer
April 21, 2023 / Tubulis / Antibody-Drug / Cancer – German biotech Tubulis announced on Thursday a strategic license agreement with the global pharmaceutical company Bristol Myers Squibb (BMS) to develop safer and more effective antibody-drug conjugates (ADCs) to treat solid tumors in cancer patients. Read Full Article on Biospace >>
Metrodora opens neuroimmune research center in Salt Lake City, reveals first biotech partners
April 19, 2023 / Biobanking / Neurological Disorders / Argenx – The Metrodora Institute has opened the doors of its medical and research center in Salt Lake City, giving biopharma companies a new neuroimmune drug development and clinical trial partner in Utah. Read Full Article on Fierce Biotech >>
J&J leans on cancer drug sales to maintain first quarter growth
April 18, 2023 / J&J / Drug Sales / First Quarter – Johnson & Johnson relied on its portfolio of cancer drugs to sustain pharmaceutical sales growth in the first quarter, offsetting weakening demand and loss of exclusivity for older medicines. Read Full Article on Biopharma Dive >>
GSK to buy Bellus Health and its chronic cough drug for $2B
April 18, 2023 / GSK / Bellus Health / New Drug / Cough Drug – With the Bellus deal, GSK will gain a drug that could compete with a similar treatment being developed by Merck & Co. Both medicines are designed to work by targeting a receptor known as P2X3, and could become the first therapies for refractory chronic cough. Read Full Article on Biopharma Dive >>
GSK faces strike threat in UK, again, after workers pan pay raise
April 19, 2023 / GSK / United Kingdom / Job Satisfaction / Strike – After skirting industrial action in 2022, GSK faces looming strikes across six of its sites in the United Kingdom next month, with hundreds of workers plotting walkouts in pursuit of better pay. Read Full Article on Fierce Pharma >>

// 4th Industrial Revolution

The 6 riskiest medical and IoT devices deployed in healthcare
April 18, 2023 / Healthcare / loT Devices – Among Internet of Things devices used in medical settings, Internet Protocol (IP) cameras are the most vulnerable to hackers. Meanwhile nurse call systems hold that troubling distinction among general medical devices. Read Full Article on AI in Healthcare >>
Provider digital health chief and venture capitalist talk AI, partnerships
April 19, 2023 / Digital Health / AI / GSR Ventures – Michael Hasselberg, RN, PMHNP-BC, chief digital health officer at the University of Rochester Medical Center, and Dr. Justin Norden, a partner at GSR Ventures, a $3.5 billion assets under management venture firm investing in early-stage digital health companies, are jointly attending HIMSS23 and have a lot on their minds. Read Full Article on Healthcare IT News >>
Generative AI growing big in the year ahead, physician expert says
April 20, 2023 / AI / HIMSS23 – The growing use of artificial intelligence and the explosive presence of generative AI (like ChatGPT) are lighting up the realm of healthcare information technology. The keys are where to use AI and how to safely use it. Read Full Article on Healthcare IT News >>
CVS Acquires Telehealth Service to Bring Healthcare to the Home
April 13, 2023 / CVS / Telehealth / Healthcare – In 2019, CVS Health announced that its MinuteClinic virtual Video Visit program was available in 39 states. Last month, CVS Health finalized itsacquisition of Signify Health, which opens the door for virtual medical services throughout the U.S. In an earlier news release, just before the final stitches in the acquisition, Signify Health identified itself as “a leading health care platform that leverages advanced analytics, technology, and nationwide healthcare provider networks to create and power value-based payment programs.” Read Full Article on Healthcare Tech Insider >>
AI needs rules and regulations to evolve effectively
April 18, 2023 / AI / HIMSS23 / Machine Learning – During the Machine Learning and AI for Healthcare Forum at the 2023 HIMSS Global Health Conference & Exhibition here on Monday, panelists discussed the good, the bad and the possibilities for artificial intelligence. Read Full Article on Mobi Health News >>

// Business & Markets

FDA again delays Daiichi’s plans to challenge Astellas and Novartis for blood cancer market
April 21, 2023 / Daiichi Sankyo / FDA / Acute Myeloid Leukemia / FDA Delay – Daiichi Sankyo’s long wait for approval of quizartinib just grew a little longer. Having bounced back from a 2019 rejection, the Japanese drugmaker has now learned the FDA needs another three months to review its second attempt to launch a challenger to Astellas and Novartis in a blood cancer market. Read Full Article on Fierce Biotech >>
Merck & Co. inks $11B Prometheus takeover, firing starting gun on race for blockbuster bowel market
April 17, 2023 / Merck & Co / Roivant / Inflammatory Bowel Disease / Mergers and Acquisitions – Merck & Co. is paying $10.8 billion to buy Prometheus Biosciences for its late-phase bowel disease drug candidate. Months after midphase data sent Prometheus’ stock spiraling upward, Merck has agreed to a 75% premium over the biotech’s prior closing price to land a challenger to Roivant Sciences’ RVT-3101. Read Full Article on Fierce Biotech >>
J&J opens the valve on $50M MS partnership with Pipeline
April 17, 2023 / Janssen Pharmaceuticals / Pipeline Therapeutics / Johnson & Johnson / Multiple Sclerosis – Johnson & Johnson is turning on the tap for Pipeline Therapeutics in a $50 million upfront licensing deal for an oral multiple sclerosis drug that could net the small biotech up to $1 billion down the line. Read Full Article on Fierce Biotech >>
In Pfizer’s $43B acquisition of Seagen, the biotech’s patience paid off
April 17, 2023 / Pfizer / Seagen / Merck / Clay Siegall – In May of last year, after Seagen rejected Merck’s offer to acquire it for $230 per share, the Seattle biotech saw its value tumble. Just three months later, Merck’s offer had dropped to $195 per share. Read Full Article on Fierce Pharma >>
Bristol Myers pays $23M to develop solid tumor ADCs based on Tubulis’ toxicity-taming technology
April 20, 2023 / Tubulis / Bristol Myers Squibb / Antibody-drug Conjugates / Solid Tumor – Bristol Myers Squibb is getting deeper into antibody-drug conjugates (ADCs), paying Tubulis $22.8 million upfront to access technology designed to create more stable drugs with improved risk-benefit profiles. Read Full Article on Fierce Biotech >>

// Legal & Regulatory

Appeals court sides with Amgen in patent fight over psoriasis drug Otezla
April 20, 2023 / Appeals Court / Amgen / Otezla / Patent / Psoriasis – The court victory offers breathing room as Amgen faces several sources of competition for Otezla. The medicine was the biotech giant’s third-best selling drug last year, with worldwide revenue of $2.3 billion. Read Full Article on Biopharma Dive >>
Amgen nabs appeals win against Otezla generics, blocking Sandoz and Zydus copycats until 2028
April 20, 2023 / Amgen / Otezla / Zydus / Sandoz – The U.S. Court of Appeals for the Federal Circuit backed a 2021 ruling against Novartis’ Sandoz and Zydus. That prior ruling found the generics companies’ products would infringe three Amgen patents. Read Full Article on Fierce Pharma >>
After going all-in on blood cancer therapy, Gamida Cell scores big win at FDA
April 17, 2023 / Gamida Cell / FDA / Blood Cancer / Bone Marrow Stem Cells – Monday, the company scored FDA approval for Omisirge (omidubicel-onlv), an allogenic cell therapy to reduce the risk of infection in blood cancer patients. Read on Fierce Pharma >>
FDA approves earlier use of Roche’s Polivy in common form of lymphoma
April 20, 2023 / FDA Approvals / Lymphoma / Roche – The Food and Drug Administration on Wednesday approved Roche’s antibody drug Polivy for patients with a common form of lymphoma who haven’t been previously treated, substantially expanding the medicine’s use. Read on Biopharma Dive >>
AbbVie’s Qulipta gains edge on Pfizer’s Nurtec with FDA approval to prevent chronic migraines
April 18, 2023 / AbbVie / Qulipta / Migraine / Chronic Pain – The new FDA nod makes the pill the only oral calcitonin gene-related peptide (CGRP) drug approved to prevent migraines in both the episodic and chronic frequencies, AbbVie said in a Monday statement. Read on Fierce Pharma >>

// Research & Development

Moderna cancer vaccine takes positive step
April 11, 2023 / Moderna / Cancer Vaccine – It concerns the adjuvant treatment of patients with high-risk stage III/IV melanoma following complete resection. The vaccine mRNA-4157/V940 stimulates an immune response by generating specific T cell responses based on the unique mutational signature of a patient’s tumour. Read Full Article on Pharma Times >>
J&J study data show dramatic benefit to multiple myeloma cell therapy
April 19, 2023 / Johnson & Johnson / Myeloma / Cell Therapy – The cancer cell therapy Carvykti dramatically outperformed standard drugs in a late-stage clinical trial testing its use in earlier treatment of the blood cancer multiple myeloma, according to data from a study abstract that was briefly posted online Tuesday. Read Full Article on Biopharma Dive >>
FDA favors single dose of updated COVID shots in shift to simplify vaccination
April 18, 2023 / FDA / Covid-19 / Vaccines / Immune System – A single dose of either Pfizer’s or Moderna’s updated COVID-19 vaccines will be recommended in most cases moving forward, after the Food and Drug Administration on Tuesday updated its authorizations of the shots to simplify the recommended regimens. Read Full Article on Biopharma Dive >>
BeiGene, Novartis’ tislelizumab stages comeback with broader stomach cancer trial win
April 20, 2023 / Novartis / BeiGene / PD-1/L1 / Stomach Cancer – When BeiGene and Novartis announced a partial trial win for tislelizumab in stomach cancer, doubts started to circulate around the PD-1 inhibitor’s potential. Now, the partners have come back with broader success. Read Full Article on Fierce Pharma >>
AACR: AstraZeneca offers first look at Imfinzi’s resectable lung cancer showing, fueling a key debate
April 16, 2023 / AstraZeneca / Imfinzi / PD-1/L1 / Non-small Cell Lung Cancer – AstraZeneca has offered the first look at the benefit of a PD-1/L1 inhibitor when used both before and after surgery in resectable non-small cell lung cancer. But the data raise more questions than answers. Read Full Article on Fierce Pharma >>

// Politics

Congress targets reducing hospital outpatient payments in new bills
April 19, 2023 / Congress / New Bills – House Republicans are floating several draft bills that would significantly affect the hospital industry, including some with far-reaching policies that would authorize Medicare to pay hospitals the identical amount for the same service, regardless of where the service was performed. Read Full Article on STAT News >>
Pharmalittle: White House to tap cancer center chief to lead NIH; generic abortion pill maker sues FDA
April 20, 2023 / White House / FDA / Abortion Pill – The White House plans to nominate Monica Bertagnolli, a cancer surgeon who became director of the National Cancer Institute last fall, to lead the National Institutes of Health, according to The Washington Post. Read Full Article on STAT News >>
Powerful Senate duo drops a bipartisan PBM reform plan
April 20, 2023 / U.S. Senate / Bipartisan – The chair and ranking Republican on the Senate Finance Committee on Thursday unveiled a bipartisan list of overarching reforms to drug middlemen’s business practices that they would like to pursue. Read Full Article on STAT News >>
Senate still hasn’t made hard decisions on lowering insulin costs
April 19, 2023 / U.S. Senate / Insulin Costs – Senate Democrats are trying to cap insulin costs for every American, but they haven’t figured out the thorniest issue: exactly how to do it. Read Full Article on STAT News >>
Supreme Court delays decision in battle over abortion pillApril 19, 2023 / Supreme Court / Abortion Pill – The Supreme Court has put off a decision in a closely watched case over the abortion pill mifepristone, extending a legal freeze that was set to expire Wednesday by two days. Read Full Article on Biopharma Dive >>