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1-15 of 2206 results
FDA grants priority review for Lynparza for maintenance setting in ovarian cancer patients
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for Lynparza (olaparib) tablets (300mg twice daily) for use in platinum-sensitive, relapsed ovarian cancer patients in the maintenance setting.
Production & Manufacturing > Manufacturing > News
Canadian drugmaker Apotex unveils $184m US expansion plan
By PBR Staff Writer
Canada-based pharmaceutical firm Apotex said it will invest $184m to expand its facilities in South Florida, US, and create 150 new jobs.
Production & Manufacturing > Manufacturing > News
BeiGene to construct biologics manufacturing facility in Guangzhou, China
By PBR Staff Writer
BeiGene (Hong Kong) and Guangzhou GET Technology Development are setting up a joint venture to build a $330m commercial-scale biologics manufacturing facility in China.
Production & Manufacturing > Manufacturing > News
Sanofi, Lonza to build EUR270m biologics production facility in Switzerland
By PBR Staff Writer
Sanofi and Lonza have agreed to invest an initial CHF290m (€270m) to construct a mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland.
Production & Manufacturing > Manufacturing > News
Abzena signs antibody manufacturing development deal with University College London
Abzena has entered into a manufacturing agreement with University College London (UCL).
Production & Manufacturing > Manufacturing > News
Arix Bioscience raises £100m in IPO
Global healthcare and life science company Arix Bioscience has raised £100m in its Initial Public Offering (IPO) on the main market of the London Stock Exchange.
Production & Manufacturing > Manufacturing > News
Momenta announces FDA warning letter to contracted Glatopa’s fill/finish manufacturer
Momenta Pharmaceuticals has announced that Pfizer, Sandoz’s contracted Glatopa (glatiramer acetate injection) fill/finish manufacturing partner has received a warning letter from the FDA.
Production & Manufacturing > Manufacturing > News
Takeda acquires Ariad Pharmaceuticals
Takeda Pharmaceutical has completed its acquisition of Ariad Pharmaceuticals for $24.00 per share in cash.
Production & Manufacturing > Manufacturing > News
Pfizer, Flynn appeal against UK regulator's £89.4m fine for epilepsy drug price hike
By PBR Staff Writer
Pfizer and Flynn Pharma have appealed against the £89.4m fine imposed by the UK Competition and Markets Authority (CMA) for charging excessive and unfair prices for an anti-epilepsy drug.
Production & Manufacturing > Manufacturing > News
German pharma company Stada confirms takeover bid from two firms
By PBR Staff Writer
German drug maker Stada Arzneimittel has received two takeover proposals including a €3.5bn proposal from private equity group Cinven Partners.
Production & Manufacturing > Manufacturing > News
US appeals court allows Regeneron, Sanofi to continue selling cholesterol drug
By PBR Staff Writer
A US appeals court has stayed an order that could have prevented Regeneron Pharmaceuticals and Sanofi from selling their cholesterol drug, Praluent.
Production & Manufacturing > Manufacturing > News
Biotech companies oppose Trump’s immigration order
By PBR Staff Writer
Chief executives of over 160 biotech companies in the US have signed a letter opposing President Donald Trump's immigration order.
Production & Manufacturing > Manufacturing > News
FDA accepts Intellipharmaceutics’ NDA for Rexista to treat moderate to severe pain
The US Food and Drug Administration has accepted for filing of Intellipharmaceutics International’s New Drug Application ("NDA") seeking authorization to market its Rexista abuse-deterrent oxycodone hydrochloride extended release tablets in the 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg strengths.
Production & Manufacturing > Manufacturing > News
Novartis mulls options including IPO, spinoff for Alcon eye care unit
By PBR Staff Writer
Swiss pharma giant Novartis has said that it is considering options including an IPO or spin-off of its eye care division.
Production & Manufacturing > Manufacturing > News
Merck, Bristol-Myers and Ono Pharmaceutical agree to settle Keytruda patent suit
By PBR Staff Writer
Merck has agreed to pay $625m and royalties to Bristol-Myers Squibb and Ono Pharmaceutical to settle patent litigation over its cancer drug Keytruda.
Production & Manufacturing > Manufacturing > News
1-15 of 2206 results