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Arvinas’ experimental breast cancer drug fails to impress analysts

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Late Monday, Arvinas Inc. was forced to divulge the contents of its upcoming breast cancer data presentation, slated for the 2022 San Antonio Breast Cancer Symposium (“SABCS”). The clinical-stage biopharma was originally set to unveil the Phase II data for its lead breast cancer medication, ARV-471, on Dec. 8, 2022. But Arvinas’ and Pfizer’s joint abstract was inadvertently published early for conference participants by SABCS. Arvinas’ stock price has since fallen by 18% over the first two days of the holiday-shortened week.

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FDA grants priority review to Takeda’s dengue vaccine

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The FDA granted priority review to Takeda’s Biologics License Application for TAK-003, a dengue vaccine candidate. The vaccine to date is only approved for use in Indonesia.

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U.S. FDA declines to approve Spectrum’s lung cancer drug

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Spectrum Pharmaceuticals Inc. said on Friday the U.S. Food and Drug Administration (FDA) declined to approve its experimental lung cancer drug due to inadequate data, prompting the drugmaker to cut jobs.

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Medtronic

Medtronic cuts annual profit forecast blaming strong dollar

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Medtronic Plc on Tuesday lowered its full-year profit outlook, blaming a stronger dollar and a slower-than-anticipated recovery from supply chain disruptions.

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Teva

Generic drugmakers Teva and Sandoz make major push to biosimilars

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Generic drug makers Teva Pharmaceutical Industries and Sandoz say they are planning a significant ramp-up in production of biosimilars – copies of high-priced drugs used to treat illnesses such as rheumatoid arthritis and cancer – aiming to increase their share of an expanding market.

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Drug maker Novo Nordisk invests $744 mln to expand Danish plant

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The investment would add capacity in research and development for manufacturing of active pharmaceutical ingredients (API), the main biologically active components of medicines, to supply its global clinical trials.

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Novavax

Novavax ends COVID vaccine sale agreement with Gavi

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The company cited Gavi’s failure to procure the 350 million doses it had agreed to buy in May last year for the COVAX facility.

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Merck acquires Imago and its LSD1 inhibitors in $1.3B deal

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With a $1.36 billion buyout, Merck is bolstering its oncology program with the acquisition of Biotech Bay-based Imago Biosciences, a company focused on chronic bone marrow cancers.

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Lysogene becomes latest company to fail with AAVs in CNS disorders

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Topline data from Lysogene’s Phase II/III AAVance study showed its investigational gene therapy, LYS-SAF302, failed to meet its primary and key secondary efficacy endpoints in mucopolysaccharidosis type IIIA.

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Teva

Teva Pharma appoints Novartis, Biogen vet as new president and CEO

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Capping a tumultuous year of legal battles, Teva Pharmaceuticals has found a new president and CEO. Effective Jan. 1, 2023, Richard Francis will take the company’s reins as Kåre Schultz retires.

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