August 22, 2017
Quantum Pharma net debt reduced
Quantum Pharma posted financial results for the first half 2017 with revenue increased by 13% to £36.2M mostly from growth from the Niche Pharmaceuticals division.
pharmaceutical daily
Pharmaceuticals, Biotechnology and Life Sciences
August 22, 2017
Working to improve information on medication use during pregnancy
When women are pregnant they take care to eat right and refrain from smoking and drinking alcoholic beverages. But what…
August 18, 2017
AZ, Merck: Lynparza gets additional and braod approval in the US for ovarian cancer
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.
August 18, 2017
STADA takeover by Bain Capital and Cinven reaches minimal acceptance treshold
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.
August 18, 2017
Bella Pharmaceuticals recalls all lots of unexpired sterile drug products
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.
August 18, 2017
Nicox responds to the CRL from USFDA for latanoprostene bunod
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.
August 18, 2017
Tetraphase’s IV Eravacycline Marketing Authorization Application submitted and validated in Europe
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).
August 17, 2017
Vectura, Hikma, FDA talk on generic version for GSK’s Advair Diskus
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.
August 17, 2017
Hikma reduces net debt for $64M in 1H, revenue 1% up
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.
August 17, 2017
NiceLabel selected among 100 Great Supply Chain Partners
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.