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Capital, M&A & Industry Strategy3 weeks agoAlnylam bulls and bears fight it out after business-shaking guidance cut
While Alnylam’s recent reduced revenue guidance spooked investors, analysts remain broadly bullish on the biotech’s commercial prospects.
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Global Biotechnology & Pharmaceutical Markets3 weeks agoEuropean biotech leaders split on US-China fight for deal dominance, survey finds
While industry leaders are unsure whether the U.S. or China will prevail, they are largely united in the belief that Europe is lagging behind.
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Capital, M&A & Industry Strategy3 weeks agoGSK pledges $800M to add biologics production capabilities in Pennsylvania
Starting next year, GSK plans to demolish existing buildings and construct new facilities to support clinical and commercial supply. The investment will create more than 300...
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Regulatory Intelligence & Drug Approvals3 weeks agoViatris inks $1.65B Pacira buyout to build non-opioid pain therapy business
With an internal non-opioid program nearing approval, Viatris is picking up Pacira BioSciences for a broader pain portfolio and the associated commercial infrastructure.
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Synthetic Biology, Genomics & Advanced Therapeutics3 weeks agoReusing data could cut R&D costs and greatly increase gene editing’s reach: ARM
Leveraging recently proposed regulatory flexibilities, the gene-editing sector is working to cut R&D costs and unlock indications that were previously economically unviable, according to a new...
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Global Biotechnology & Pharmaceutical Markets3 weeks agoMerck barred from making subcutaneous Keytruda in 8 European countries
With the patent court siding with Halozyme, Merck faces restrictions on a product that won approval in Europe last year.
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Manufacturing, Supply Chain & Infrastructure4 weeks agoBayer commits $2.2B to build pharma manufacturing plant in Ohio
The investment will equip Bayer to make oncology, cardiovascular and renal care ingredients and drugs.
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Manufacturing, Supply Chain & Infrastructure4 weeks agoCompliance concerns hinder rollout of AI in drug manufacturing: Survey
While AI is taking off in biopharma for administrative tasks and drug discovery efforts, more than 90% of drugmakers have yet to commit to scaling AI...
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Manufacturing, Supply Chain & Infrastructure1 month agoFresenius Kabi manufacturing plant hit with FDA warning letter after adverse events
Patients had adverse events after receiving a Fresenius Kabi medicine that experienced manufacturing deviations.
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Manufacturing, Supply Chain & Infrastructure1 month agoBioNTech to close German manufacturing plants after failing to find buyers
Time has run out on BioNTech's bid to locate buyers for sites in Idar-Oberstein, Marburg and Tübingen. Including staff at a Singapore plant also slated for...
Widespread atropine use fails to sway FDA advisors on Sydnexis data
At least 11 PDUFAs on FDA’s November docket
FDA Grants Accelerated Approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for Recurrent Respiratory Papillomatosis
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
