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Manufacturing issues spur FDA to deny approval of Lilly colitis drug

Dive Brief: The Food and Drug Administration has rejected Eli Lilly’s request to approve an experimental ulcerative colitis drug due to manufacturing issues, delaying the …

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Merck to buy inflammatory disease drugmaker Prometheus for $10.8B

Merck & Co. has reached a deal to acquire Prometheus Biosciences for about $10.8 billion, betting an experimental drug the biotechnology company is developing will …

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Compact modular detectors for biomolecular applications

Biotech Fluidics reports that the biocompatible flow path and minimal heat output of its Runge Mikron detectors makes them perfect for analysis and preparative purification …

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bioprocessing applications

SONOTEC presents extended non-contact flow meter series at Interphex

After successfully launching the SONOFLOW® CO.55 V3.0 flow meter last year, SONOTEC presents new sensor sizes to cover a wider range of biopharmaceutical applications. Designed …

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Bluebird, awaiting FDA feedback, says it’s likely to miss filing goal for sickle cell gene therapy

Dive Brief: Bluebird bio is likely to miss its goal for submitting an experimental gene therapy for sickle cell disease to the Food and Drug …

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Pharma partner Sartorius eyes gene therapy market with $2.6B deal

Sartorius, a Germany-based manufacturer and supplier to the biopharmaceutical industry, is acquiring France’s Polyplus in a $2.6 billion acquisition meant to expand the company’s role …

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Gene therapy startup Vedere to close two years after launch

Vedere Bio II, a startup launched two years ago to develop gene therapies for the eye, is winding down. In a message posted on LinkedIn …

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Optimized degassers for GPC applications

Biotech Fluidics has announced the highly efficient degassers optimized for Gel Permeation Chromatography (GPC) applications – the DEGASi Plus GPC and  DEGASi Plus GPC Semi-Prep. …

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Iktos announces closing of €15.5M in Series A round

The round is co-led by M Ventures and Debiopharm Innovation Fund with Omnes Capital; all joining as new investors Series A will enable Iktos to …

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Stuart Peltz, founder of PTC, retires after 25 years as CEO

After 25 years as CEO of PTC Therapeutics, Stuart Peltz is stepping down from his role as head of the rare disease drugmaker. The company announced …

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Sanofi, Regeneron surge as Dupixent scores in COPD trial

Dive Brief: An anti-inflammatory drug from Sanofi and Regeneron succeeded in a Phase 3 clinical trial in chronic obstructive pulmonary disease, giving the medicine, Dupixent, …

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Former Seagen CEO Siegall returns to biotech as head of early-stage startup

Nearly one year after being ousted as CEO of Seagen, Clay Siegall is back at the helm of a biotechnology company. On Thursday, he was …

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Biotech startups face ‘Series A cliff’ as venture capital stays cautious

The rapid demise of Silicon Valley Bank put an unwelcome spotlight on the financial position of many small biotechnology companies that relied on the storied …

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FDA reversal sets up high-stakes hearing on Sarepta gene therapy

Dive Brief: The Food and Drug Administration will convene a panel of experts to review Sarepta Therapeutics’ application for approval of a muscular dystrophy gene …

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Merck TIGIT drug misses goal in lung cancer trial, adding to doubts over approach

Dive Brief: An experimental Merck & Co. drug that pairs Keytruda with a new type of immunotherapy did not help people with lung cancer in …

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In Pfizer-Seagen review, FTC has chance to set new pharma precedent

Pfizer’s planned $43 billion acquisition of Seagen will be a major test for the Federal Trade Commission since the monopoly-regulating agency revised its views of …

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Takeda, chasing Bristol Myers, unveils awaited TYK2 drug data

Three months ago, Japanese pharmaceutical giant Takeda paid a biotechnology startup $4 billion for an experimental drug in one of the largest deals of its …

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Sanofi joins other diabetes drugmakers in cutting insulin prices

Dive Brief: Sanofi said Thursday it will cut the prices for its insulin products by as much as 78%, following two of its rivals who …

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PCI Pharma Services Expands Biologics Leadership with new Center of Excellence Facility in the Midwest

New Building at Rockford, Illinois site will significantly increase equipment and capacity for injectable biologics and other self-administered therapies   PCI Pharma Services (PCI), a …

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FDA finds at least 19 cases of skin cancer in breast implant data, including 3 deaths

Though the FDA has long been aware of the risk that some people with breast implants may develop a rare form of T-cell lymphoma—now known …

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