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FDA calls for stronger potency upkeep in CGT manufacturing
The FDA’s CBER director said patients should have assurance that administered products will work as intended.
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Pharma Tech
AbbVie inks $757m migraine-focused deal with Brise PharmaceuticalsÂ
AbbVie and Brise have shared details on this migraine deal two years after the pair originally forged it.
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Pharma Tech
Lonza to acquire five US manufacturing sites from Merck KGaA
Lonza has entered an agreement for the acquisition of five US CDMO sites from Merck KGaA, bringing 1,100 employees into Lonza's workforce.
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Pharma Tech
Bavarian Nordic secures four-year UK vaccine supply deal
Bavarian Nordic has secured a four-year contract from the UK Government to supply its MVA-BN vaccine, used for the prevention of mpox and smallpox.
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Express Pharma
US FDA grants tentative approval for Dr. Reddy’s twice-yearly injectable lenacapavirÂ
Under the existing agreement, injectable lenacapavir will be available at US$40 per person per year across 120 countries covered by Gilead’s voluntary licence. The post US FDA grants tentative approval for Dr. Reddy’s twice-yearly injectable lenacapavir appeared first on Express Pharma.
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Pharma Tech
Nov 3, 2026, 4:23 PM
FDA calls for stronger potency upkeep in CGT manufacturing
The FDA’s CBER director said patients should have assurance that administered products will work as intended.
Pharma Tech
Nov 3, 2026, 2:21 PM
AbbVie inks $757m migraine-focused deal with Brise PharmaceuticalsÂ
AbbVie and Brise have shared details on this migraine deal two years after the pair originally forged it.
PharmaShots
Nov 3, 2026, 11:36 AM
Merck KGaA to Divest its CDMO Business to Lonza
Shots: Merck KGaA has signed a definitive agreement to divest the CDMO business of its Life Science sector to Lonza for a mid-triple-digit million-euro amount, with closing expected in mid-2027, subject to regulatory approvals & other conditions The deal covers development & manufacturing services for complex modalities across sites in Carlsbad (CA), Madison & Verona… The post Merck KGaA to Divest its CDMO Business to Lonza appeared first on PharmaShots.
PharmaShots
Nov 3, 2026, 11:36 AM
Teva and Samsung Bioepis Enter into an Agreement to Commercialize Two FDA-Approved Biosimilars in the US
Shots: Teva & Samsung Bioepis have entered a license & commercialization agreement for 2 FDA-approved immunology biosimilars in the US: infliximab-abda (biosimilar to Remicade) & ETICOVO (etanercept-ykro; biosimilar to Enbrel) Teva will gain US commercialization rights to etanercept-ykro at closing & to infliximab-abda in Q3’27, while Samsung Bioepis remains responsible for regulatory oversight & manufacturing;… The post Teva and Samsung Bioepis Enter into an Agreement to Commercialize Two FDA-Approved Biosimilars in the US appeared first on PharmaShots.
PharmaShots
Nov 3, 2026, 11:34 AM
Rhythm Pharmaceuticals and LG Chem Amend Exclusive License Agreement for Bivamelagon
Shots: Rhythm Pharmaceuticals has amended its global exclusive license agreement with LG Chem for bivamelagon (formerly LB54640), an investigational oral small-molecule MC4R agonist Rhythm will pay 50M in 4 fixed installments through Sep 2029 (0M upfront), while the prior low-to-mid-single-digit royalty is replaced by a 1% royalty on global sales of its MC4R portfolio from… The post Rhythm Pharmaceuticals and LG Chem Amend Exclusive License Agreement for Bivamelagon appeared first on PharmaShots.
PharmaShots
Nov 3, 2026, 11:34 AM
Cerus Reports Topline Results from the P-III (RedeS) Trial of INTERCEPT Blood System for Red Blood Cells
Shots: Cerus has reported topline results from the P-III (RedeS) trial (NCT03037164) evaluating the INTERCEPT Blood System for red blood cells (RBCs) vs conventional RBCs in patients requiring transfusion support The trial met its 1EP of non-inferiority by adjusted hemoglobin increment in the mITT population (1.996 vs 2.050g/dL; difference: -0.054g/dL; p=0.004), with no significant difference… The post Cerus Reports Topline Results from the P-III (RedeS) Trial of INTERCEPT Blood System for Red Blood Cells appeared first on PharmaShots.
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Google News
Nov 3, 2026, 5:58 PM
COINS Act could upend China biotech deals, as Korea eyes opening - BioWorld News
COINS Act could upend China biotech deals, as Korea eyes opening  BioWorld News
Google News
Nov 3, 2026, 5:29 PM
Drugmakers may need designated expert to certify batches before sale - Livemint
Drugmakers may need designated expert to certify batches before sale  Livemint
Google News
Nov 3, 2026, 5:28 PM
Roundup settlement expected before Christmas, Bayer CEO says - Reuters
Roundup settlement expected before Christmas, Bayer CEO says  Reuters
Google News
Nov 3, 2026, 5:14 PM
ELPRO CEO on How Biologics Raised the Stakes in Cold Chain Handling - Pharmaceutical Commerce
ELPRO CEO on How Biologics Raised the Stakes in Cold Chain Handling  Pharmaceutical Commerce
Google News
Nov 3, 2026, 5:09 PM
India’s affordable medicines, digital health model emulatable: Report - Social News XYZ
India’s affordable medicines, digital health model emulatable: Report  Social News XYZ
Google News
Nov 3, 2026, 5:09 PM
NPPA updates list of reduced MRP of 1,085 anti-cancer drugs - The Economic Times
NPPA updates list of reduced MRP of 1,085 anti-cancer drugs  The Economic Times
Google News
Nov 3, 2026, 5:02 PM
Teva Pharmaceutical Industries Limited 2026 Q3 - Results - Earnings Call Presentation (NYSE:TEVA) 2026-11-03 - Seeking Alpha
Teva Pharmaceutical Industries Limited 2026 Q3 - Results - Earnings Call Presentation (NYSE:TEVA) 2026-11-03Â Â Seeking Alpha
Google News
Nov 3, 2026, 5:00 PM
Evonile Pharma Limited Schedules November 4 FY27 Earnings Call - Multibagg AI
Evonile Pharma Limited Schedules November 4 FY27 Earnings Call  Multibagg AI
Google News
Nov 3, 2026, 5:00 PM
AGC Biologics Adds Copenhagen Site to Deal with Global Pharma Company - Contract Pharma
AGC Biologics Adds Copenhagen Site to Deal with Global Pharma Company  Contract Pharma
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