AstraZeneca’s and Merck’s Lynparza new tablet’s formulation has been approved as maintenance treatment for women with platinum-sensitive recurrent ovarian cancer regardless of BRCA-mutation status, the companies said Friday.Read more
Nidda Healthcare Holding AG, the acquiring company of Bain Capital und Cinven, announced Friday that the minimum acceptance threshold set by the bidder at 63 percent in the offer document published on July 19, 2017 was reached.Read more
Bella Pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance. The recalled products were distributed to health care facilities in the USA.Read more
Paris-listed international ophthalmic company Nicox, on Friday said that its exclusive licensee has said it has submitted a response to the Complete Response Letter (CRL) received from the U.S. Food and Drug Administration (FDA) on August 7, 2017 concerning the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024% for the reduction of intraocular pressure in patients with glaucoma or ocular hypertension.Read more
Tetraphase Pharmaceuticals, a clinical-stage biopharmaceutical company said on Thursday that the Marketing Authorization Application (MAA) for IV eravacycline for the treatment of complicated intra-abdominal infections (cIAI) has been submitted and was validated by the European Medicines Agency (EMA).Read more
Vectura Group confirmed on Thursday what its partner Hikma Pharmaceuticals said in its interim results statement about its abbreviated new drug application (ANDA) filing for a US generic version of Advair Diskus.Read more
During H1 2017, the Generics business launched 7 products, including all dosage forms and strengths, and received 14 product approvals.
We announced on 11 May 2017 that the US Food and Drug Administration (FDA) had issued a complete response letter (CRL) in relation to our abbreviated new drug application (ANDA) for our generic version of GlaxoSmithKline’s Advair Diskus® (fluticasone propionate and salmeterol inhalation powder). Since then we, supported by our partner Vectura, have had constructive discussions with the FDA and we have been able to clarify and resolve a number of the questions raised. The discussions with the FDA have confirmed our initial assessment that there are no material issues regarding the substitutability of the proposed device. We are in ongoing discussions with the FDA to address the remaining questions and will provide a more detailed update to the market as soon as we are able to do so.
We now expect Generics revenue to be around $620 million for the full year, reflecting the impact of increased competition on prices and volumes. Through our focus on portfolio optimisation and continued cost savings, we expect the Generics business to achieve core operating profit of around $30 million in 2017.Read more
NiceLabel has been chosen to the SupplyChainBrain’s annual list of the top 100 providers whose solutions have made significant impact on companies’ efficiency, customer service and overall supply chain performance.Read more
Israel-based RedHill Biopharma, a biopharmaceutical company focused on drugs for gastrointestinal and inflammatory diseases and cancer, has made a deal with ParaPRO, an Indiana-based pharmaceutical company, granting RedHill the exclusive rights to promote Esomeprazole Strontium Delayed-Release Capsules to gastroenterologists in certain U.S. territories.Read more
Bristol-Myers Squibb announced results from the CheckMate -214 trial on Tuesday, investigating Opdivo (nivolumab) in combination with Yervoy (ipilimumab) versus sunitinib in intermediate and poor-risk patients previously untreated advanced or metastatic renal cell carcinoma.Read more