Celgene Corporation (CELG) and Impact Biomedicines today announced the signing of a definitive agreement in which Celgene will acquire Impact Biomedicines, which is developing fedratinib for myelofibrosis and polycythemia vera. Under the terms of the agreement, Celgene will pay approximately $1.1 billion upfront and up to $1.25 billion in contingent payments based on regulatory approval milestones for myelofibrosis. Additional future payments for regulatory approvals in additional indications and sales-based milestones are also possible.
Celgene Corporation and bluebird bio, Inc. announced that bb2121, a chimeric antigen receptor T-cell (CAR-T) therapy targeting b-cell maturation antigen (BCMA) in previously treated patients with multiple myeloma, has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) and PRIority MEdicines (PRIME) eligibility by the European Medicines Agency (EMA).
ARMO BioSciences, Inc., a late-stage immuno-oncology company, today announced the successful completion of a $67 million Series C-1 private financing. The Series C-1 proceeds will be used to initiate phase 2/3 studies with ARMO's lead immunotherapy agent AM0010 in non-small cell lung cancer(NSCLC) and renal cell cancer and to support an ongoing pivotal phase 3 clinical trial in advanced pancreatic cancer.
As Eli Lilly’s Kisunla (donanemab) enters the Alzheimer’s treatment space, its leading competitor Biogen is undergoing therapy diversification after completing its $1.15bn acquisition of Human Immunology Biosciences (HI-Bio). The deal, which was agreed upon in May this year and includes $650m in milestone payments, sees Biogen bolster its pipeline with US-based HI-Bio’s anti-CD38 monoclonal antibody candidate felzartamab. Biogen’s head of development Priya Singhal said the company is “very excited” about the addition of felzartamab to its rosters in a 2 July press release, adding that Biogen will advance the candidate to Phase III now the transaction is complete. Felzartamab has already demonstrated positive Phase II data in a range of immune-mediated diseases, including IgA nephropathy (IgAN), antibody-mediated rejection (AMR), and primary membranous nephropathy (PMN). The Phase III development plans are for all three diseases, according to Biogen. Felzartamab was originally developed by MorphoSys as a possible competitor to Johnson & ...
By Kate Goodwin Pictured: Closed sign/iStock, StockSeller_ukr After a couple of disappointing years, a microbiome biotech founded by Flagship Pioneering is calling it quits. In an SEC filing Monday, Evelo Biosciences reported that dissolution is “in the best interest” of the company as well as its creditors and stockholders. The company was launched in 2015 by Flagship to develop inflammation-resolving microbe medicines to act on cells in the small intestine with systemic therapeutic effects for inflammatory diseases. However, the past two years have been tough for Cambridge, Mass.-based Evelo as one by one each of its assets disappointed. After a Phase II failure in April 2022, its second atopic dermatitis candidate in Phase II testing did not meet the trial’s primary endpoint in February 2023. The company pointed to an unusually high placebo response rate. The results sent Evelo’s stock tumbling 50% at the time and the company cut around ...
Biopharma M&A is on an uptick compared to the post-pandemic doldrums of the last two years. Analysts anticipate that the trend will continue in 2023 and into 2024 as companies attempt to beef up their portfolios.During second quarter earnings calls, many heavy-hitters—including Johnson & Johnson, Bristol Myers Squibb and Merck—expressed urgency in their quest for deals. With so many buyers in competition, sellers are finding offers that are more attractive. For example, Merck’s $10.8 billion proposal to acquire Prometheus in April came at a 75% premium. In July, Biogen’s $7.3 billion deal for Reata represented a 59% markup. “There’s been such a consistent pick up in momentum in anything above a billion [dollars],” Cody Powers, an M&A expert with ZS Principal, said in an interview. “I think we’re back on the gravy train of where we were a couple of years ago in terms of premiums.” In 2019, the industry ...
After 10 years on the market, the Bristol Myers Squibb and Celgene blockbuster multiple myeloma treatment Pomalyst has landed in some legal hot water.In a new lawsuit (PDF), Blue Cross and Blue Shield of Louisiana claims Celgene used an illegal scheme to protect the drug’s monopoly, causing purchasers to overpay by “hundreds of millions, if not billions” of dollars over the years. BMS did not immediately respond to Fierce Pharma’s request for comment. The company acquired Pomalyst in its $74 billion buyout of Celgene in 2019. In the suit, Blue Cross and Blue Shield of Louisiana says Celgene sought fraudulent patents, abused the federal judicial system and shared some of its “illicitly acquired” profits with generic drug makers to keep competition at bay. Specifically, Celgene knowingly secured certain patents using information that was already in the public domain, Blue Cross argues. To protect these patents, Celgene initiated lawsuits against would-be ...
By Tristan Manalac Pictured: BMS office in California/iStock, hapabapaBlue Cross and Blue Shield of Louisiana on Tuesday filed a class action lawsuit against Bristol Myers Squibb, accusing the pharma giant of unlawfully extending the market exclusivity for its multiple myeloma drug Pomalyst (pomalidomide), according to Reuters. The Baton Rouge-based health maintenance organization is being joined by HMO Louisiana, a subsidiary of Blue Cross and Blue Shield of Louisiana. The plaintiffs are representing a proposed class of entities in the U.S. and its territories that paid for or reimbursed Pomalyst from October 2020. In the 151-page complaint, the not-for-profit health insurance company alleged that BMS and its subsidiary Celgene committed patent fraud by misrepresenting and concealing data regarding Pomalyst’s properties, formulations and uses that had already been publicly available. The pharma companies also “abused the federal judicial system” by launching a barrage of “sham lawsuits” against generics companies that were trying ...
Drug shortages have been in the news for several years, but they worsened during the Covid-19 pandemic, and several pharmacy, regulatory, and physician organisations, in the US and Europe, have recently issued alerts in response. In May, the American Cancer Society declared that chemotherapy drugs were among the top-five drug classes affected by shortages, and numerous oncology medications are currently in short supply according to data from the US Food and Drug Administration (FDA). “The shortages of oncology drugs are primarily in the generic drug market,” says Dr. Kevin Shulman, a professor of medicine and clinical hospitalist at the Clinical Excellence Research Center at Stanford University. There is no financial incentive for big pharma to manufacture older generic medications that are critical to the treatment of several common cancers and very few companies invest in doing so, says Dr. Kristen Rice, medical oncologist with a practice in San Diego, California. ...
Amgen has announced positive new research evaluating the use of its inflammatory disease medication Otezla (apremilast) in psoriatic arthritis. Psoriatic arthritis is a chronic, inflammatory form of arthritis estimated to affect nearly 38 million people worldwide. The condition can cause swelling, stiffness and pain in and around the joints that worsens over time and can decrease physical function. Otezla regulates inflammation by inhibiting an enzyme known as phosphodiesterase 4. This enzyme controls much of the inflammatory action within cells, which can affect the level of inflammation associated with psoriatic disease. The new data for the drug, being presented at the 2023 European Congress of Rheumatology (EULAR), includes results from the phase 4 MOSAIC study, which evaluated its effect on joint inflammation and structural progression of psoriatic arthritis using MRI. Results showed that patients treated with Otezla had improvements in both clinical and MRI measures of inflammation up to week 48, ...
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