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31-45 of 2296 results
Celonic acquires Glycotope’s bio-manufacturing plant in Germany
Celonic, a privately owned CDMO based in Basel, Switzerland, has completed the acquisition of Glycotope’s bio-manufacturing facility in Heidelberg, Germany.
Production & Manufacturing > Manufacturing > News
FDA approves new dosing for Xarelto to reduce risk of VTE
Janssen Pharmaceuticals reported that 10mg once-daily dose of Xarelto (rivaroxaban) has been approved by the US Food and Drug Administration (FDA) for reducing the continued risk for recurrent venous thromboembolism (VTE) after at least six months of initial anticoagulation therapy.
Production & Manufacturing > Manufacturing > News
Lannett, Celgene sign settlement and license agreement related to Thalomid
Lannett has entered into a settlement and license agreement with Celgene, which resolves patent infringement litigation in the US related to Celgene's Thalomid.
Production & Manufacturing > Manufacturing > News
Novartis to buy nuclear medicine firm Advanced Accelerator Applications for $3.9bn
By PBR Staff Writer
Novartis has agreed to acquire French radiopharmaceutical company Advanced Accelerator Applications (AAA) for $3.9bn to strengthen its oncology presence.
Production & Manufacturing > Manufacturing > News
Teva loses Copaxone patent dispute case to Mylan in UK
By PBR Staff Writer
The UK High Court of Justice has given a decision in favor of Mylan and Synthon over their dispute concerning the patent of Teva Phamaceutical Industries’ multiple sclerosis (MS) treatment Copaxone which was ruled to be invalid due to obviousness.
Production & Manufacturing > Manufacturing > News
Regeneron Pharmaceuticals to invest $100m in Irish facility
By PBR Staff Writer
US-based Regeneron Pharmaceuticals will invest an additional $100m to expand its bioprocessing campus in Limerick, Ireland, to increase its drug substance production capacity.
Production & Manufacturing > Manufacturing > News
Clinigen acquires Japanese unlicensed medicines supplier
Clinigen Group has acquired International Medical Management (IMMC), Japan’s largest supplier of unlicensed medicines, for an undisclosed sum.
Production & Manufacturing > Manufacturing > News
Teva seeks FDA approval for migraine drug fremanezumab
By PBR Staff Writer
Israel-based Teva Pharmaceutical Industries is seeking approval of its migraine drug fremanezumab in the US having filed a Biologics License Application (BLA) with the US Food and Drug Administration (FDA).
Production & Manufacturing > Manufacturing > News
Amneal to acquire Impax to expand generics business in US
By PBR Staff Writer
Amneal Pharmaceuticals has agreed to buy Impax Laboratories in an all-stock deal to create a diversified pharmaceutical firm that is expected to become the fifth largest generics business in the US.
Production & Manufacturing > Manufacturing > News
Lupin buys Symbiomix to expand women’s health specialty business
By PBR Staff Writer
Mumbai-based Lupin’s US subsidiary has acquired Symbiomix Therapeutics for $150m in an all-cash deal to expand its branded women’s health specialty business.
Production & Manufacturing > Manufacturing > News
Sanofi to invest €170m for expansion of French vaccine manufacturing facility
By PBR Staff Writer
Sanofi is set to invest around €170m to expand its vaccine manufacturing facility in Val de Reuil, France.
Production & Manufacturing > Manufacturing > News
Merck halts development of MK-3682B and MK-3682C programs
Merck announced its strategic decision to discontinue the development of the investigational combination regimens MK-3682B (grazoprevir/ruzasvir/ uprifosbuvir) and MK-3682C (ruzasvir/uprifosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection.
Production & Manufacturing > Manufacturing > News
Roche's Perjeta regimen secures FDA priority review in breast cancer
The US Food and Drug Administration (FDA) has granted priority review for Roche’s Perjeta in combination with Herceptin and chemotherapy to treat HER2-positive early breast cancer after surgery.
Production & Manufacturing > Manufacturing > News
Catalent to acquire Indiana-based CDMO Cook Pharmica for $950m
By PBR Staff Writer
Catalent has agreed to acquire Indiana-based contract development and manufacturing organization (CDMO) Cook Pharmica for $950m to consolidate its position in the bio-pharma sector.
Production & Manufacturing > Manufacturing > News
CHMP recommends GSK, Innoviva’s single inhaler triple therapy for COPD
By PBR Staff Writer
GlaxoSmithKline (GSK) and Innoviva announced that a committee of the European Medicines Agency (EMA) has adopted positive opinion for fluticasone furoate/ umeclidinium/vilanterol (FF/UMEC/VI) in treating chronic obstructive pulmonary disease (COPD) in adults.
Production & Manufacturing > Manufacturing > News
31-45 of 2296 results