Industry News

- Read more about AcelRx Pharmaceuticals Receives Notice of Eligibility for Centralized Review of ARX-04 from EMA
AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the intended treatment of acute pain, reported that the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has confirmed that a Marketing Authorization Application (MAA) for ARX-04 may be submitted in the European Union (EU) under the Agency's centralized procedure. ARX-04 (sufentanil sublingual tablet, 30 mcg) is being developed for the treatment of moderate-to-severe acute pain in adult patients administered by a healthcare professional in a medically supervised setting.
- Read more about Aurobindo Pharma receives USFDA Approval for Famotidine Tablets
Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Famotidine Tablets USP, 20 mg and 40 mg.
- Read more about Celgene Settles REVLIMID® Patent Litigation
Celgene Corporation announced the settlement of litigation with Natco Pharma Ltd. of India, Natco's U.S. partner, Arrow International Limited, and Arrow's parent company, Watson Laboratories, Inc. (a wholly-owned subsidiary of Allergan plc) relating to patents for REVLIMID® (lenalidomide).
- Read more about Merck’s investigational Ebola vaccine for Emergency Use Assessment and Listing accepted for review by WHO
Merck, known as MSD outside the United States and Canada, announced that the application for Emergency Use Assessment and Listing (EUAL) for the company’s investigational Ebola Zaire vaccine, V920 (rVSV?G-ZEBOV-GP, live attenuated), has been accepted for review by the World Health Organization (WHO).
- Read more about Oral REVLIMID® Plus Dexamethasone Granted Approval for Treatment of Patients with Newly Diagnosed Multiple Myeloma in Japan
Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation announced that REVLIMID® (lenalidomide), a cancer medicine that is administered orally, has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare (MHLW) for use in combination with dexamethasone as a treatment for patients newly diagnosed with multiple myeloma. This marketing authorization expands upon the approval of REVLIMID in 2010 for the treatment of patients with relapsed or refractory multiple myeloma.
- Read more about Recipharm collaborate with Alcon & acquires facility in France
Recipharm AB, a leading contract development and manufacturing organisation in the pharmaceutical industry, has entered into the previously announced strategic collaboration with Alcon, a Novartis company, and signed a long term supply agreement whereby Recipharm will manufacture a range of ophthalmic products using Blow Fill Seal technology.
- Read more about Sanofi get Philippines approval to market dengue vaccine
Sanofi Pasteur, the vaccines division of Sanofi, announced that the Philippines have granted marketing approval to Dengvaxia®, making it the first vaccine to be licensed for the prevention of dengue in Asia.
- Read more about Iran's Pharmaceutical sector to become a pharma powerhouse post sanction era - Biotechnology sector to have lucrative opportunities
With annual consumption of 30 billion units of various generic medicines, Iran, the second-biggest consumer of generics in the Asian continent spent over USD 4.5 billion on drugs in 2015. While per capita consumption of generic drugs is three times higher than average per capita consumption in the world, biological medicines and drugs for special diseases suffers from limited access. Cardiovascular, Anti-Cancer & chemotherapy drugs, MAB, pain relievers & Hydrocortisones, Anti infections, Plasma products & Recombinants as well as Diabetes control over 55% of the total sales market. Solid dose (Tablet &Capsules) and injection forms control 42% and 38% of total sales market, respectively.
- Read more about Biocon introduces CIMIVIR-L™ for Hepatitis-C in India
Biocon Ltd, Asia's premier biotechnology company, introduces an advanced novel therapy CIMIVIR-L™ for the treatment of Hepatitis C in India. CIMIVIR-L™ is a fixed dose combination of Ledipasvir 90 mg and Sofosbuvir 400 mg, which is an equivalent of the innovator product commercialized by Gilead Sciences in the US.
- Read more about Boehringer Ingelheim Expands Biopharmaceutical Production at Vienna Site
Boehringer Ingelheim will make a significant investment in biopharmaceutical production at its Vienna (Austria) site. There the research-driven pharmaceutical company will establish a new large-scale biopharmaceutical production facility for active ingredients manufactured using cell cultures. With the roughly half billion euro investment Boehringer Ingelheim will also create more than 400 new jobs in the Austrian capital. The exact investment and job numbers will be established as details are ironed out.