New York
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Better late than never? Axsome depression drug is approved a year after FDA delay
The FDA has approved Axsome Therapeutics drug Auvelity as a treatment for major depressive disorder in adults. The regulatory decision makes the twice-daily pill the first new oral drug approved to address a novel depression target in more than 60 years.
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Pfizer to buy sickle cell disease biotech Global Blood Therapeutics in $5.4B deal
Pfizer’s own R&D efforts in sickle cell disease have fallen short, so the pharmaceutical giant is turning to M&A to gain a presence in the blood disorder. The acquisition of Global Blood therapeutics brings the commercialized drug Oxbryta plus a pipeline of other therapeutic candidates.
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Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
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Regeneron is paying $900M for full rights to cancer drug partnered with Sanofi
Regeneron Pharmaceuticals has big plans for cancer immunotherapy Libtayo and it believes it can better execute on them if it has full control of the drug, currently partnered with Sanofi. Regeneron struck a deal to pay Sanofi $900 million, plus another $200 million in milestones, to secure full global rights to the asset.
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After Haleon splits from GSK, Pfizer plans to cash out to the tune of $16B
When consumer healthcare products joint venture Haleon spins out from GSK as an independent company next month, Pfizer will sell its minority stake in the business. Pfizer said that selling its ownership in Haleon is keeping with its focus on developing innovative new medicines and vaccines.
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Potential blockbuster BMS cardio drug gets FDA nod, first in rare heart disease
Bristol Myers Squibb drug Camzyos has FDA approval for treating obstructive hypertrophic cardiomyopathy, a rare and potentially fatal heart disorder. The drug is projected to become a blockbuster seller and its approval marks a payoff for BMS’s 2020 acquisition of the medicine’s developer, MyoKardia.
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Regeneron captures new piece for cancer with $250M Checkmate Pharma buyout
Regeneron Pharmaceuticals is paying $250 million cash to acquire Checkmate Pharmaceuticals, a clinical-stage biotech developing drugs that activate the innate immune system. The biotech’s lead drug candidate is currently in pivotal testing in melanoma.
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BMS nabs FDA nod for first drug in new class of cancer immunotherapies
Bristol Myers Squibb’s Opdualag has been approved by the FDA, a first for a drug that goes after a new cancer target called LAG-3. The drug is approved for advanced melanoma as part of a combination treatment that includes the already approved BMS cancer immunotherapy Opdivo.
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Artificial Intelligence, BioPharma, Health Tech
Sanofi and DarioHealth team up on digital health tools for chronic conditions
Sanofi and digital therapeutics company DarioHealth will work together to promote the tech firm’s offerings for the management of chronic diseases. Under the $30 million, multi-year agreement, the partners will also develop new technology tools.
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Pfizer bows out of developing cardio drug, returns rights to Ionis Pharmaceuticals
After reviewing Phase 2B clinical data, the New York drugmaker and its partner Ionis Pharmaceuticals announced that Pfizer was abandoning the development of a cardiovascular drug, thereby returning the rights to Ionis.
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Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
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Clinical trials startup comes out of stealth by announcing $27.5M funding round
Topography Health announced their 27.5M series A funding for their clinical trials technology led by Andreessen Horowitz and Bain Capital Ventures.
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Medidata talent acquisition director highlights AI job growth
Andrew Bott, Director of Talent Acquisition in EMEA & APAC countries at Medidata, shared his insights on hiring trends in this sector, in response to emailed questions.
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Pfizer’s growth hormone deficiency drug comes up short at the FDA
The FDA has rejected Pfizer’s somatrogon, a long-acting form of human growth hormone designed for once-weekly dosing. The setback delays Pfizer and partner Opko Health from competing against a newly approved human growth hormone drug from Ascendis Pharma that is also designed for once-weekly dosing.
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Psychedelic biotech Eleusis enters SPAC deal to take depression drug to the clinic
Eleusis is developing a formulation of the psychedelic compound psilocybin that overcomes limitations of pill versions of the drug. Depression is Eleusis’s lead disease target but the biotech notes that its research has shown the potential to bring psychedelic drugs beyond psychiatry.
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BeyondSpring is laying off 35% of staff in wake of FDA rejection of lead drug
BeyondSpring Pharmaceuticals’ corporate reorganization comes about six weeks after the FDA rejected the biotech’s drug for a complication experienced by cancer patients. The company still plans to develop the drug for that application and others, but it added that layoffs are needed to reduce expenses.
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Pfizer and BioNTech team up again, this time to develop an mRNA shingles vaccine
Pfizer is paying BioNTech $225 million to kick off a new alliance aiming to develop a shingles vaccine based on the same messenger RNA technology that is the basis of the partners’ Covid-19 vaccine. It’s the third alliance between the two companies, but this time Pfizer brings something more to the table.