Dr Reddy's Laboratories has entered into a strategic collaboration with Amgen to market and distribute three Amgen medicines in India in the areas of oncology and cardiology. Under the terms of the collaboration, DRL will launch Kyprolis (carfilzomib), Blincyto (blinatumomab and Repatha (evolocumab) in India.
Ajanta Pharma Limited, a Rs.1,450 crore plus Mumbai based specialty focused pharmaceutical formulation company, has received final approval from the United States Food and Drug Administration (FDA) for its 3 Abbreviated New Drug Applications (ANDAs), montelukast tablets, 10mg, montelukast sodium chewable tablets, 4mg & 5mg and montelukast oral granules.
Pharma Major Lupin Limited (Lupin) today announced the opening of its new Center of Excellence for Inhalation Research in Coral Springs, Florida. Local and state leaders, including Florida Lieutenant Governor Carlos Lopez-Cantera, Florida Department of Economic Opportunity Director Jesse Panuccio, and Mayor Skip Campbell, were on site to celebrate the opening of Lupin’s new facility with a ribbon cutting ceremony.
ANI Pharmaceuticals, Inc., an integrated specialty pharmaceutical company, announced that its ANDA collaboration partner Sofgen, received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nimodipine 30mg capsules. ANI and Sofgen expect to begin shipping to customers this year.
MedPlus has recently launched e-commerce service ‘Click. Pick & Save’ in Delhi and NCR area. With this launch, the service is available in all the top metro areas of the country except Mumbai.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of Merck's investigational antibiotic Zerbaxa (ceftolozane and tazobactam). This is used for the treatment of the complicated intra-abdominal infections, acute pyelonephritis, and complicated urinary tract infections in adults.
Unichem Pharmaceuticals (USA) is a wholly-owned subsidiary of the company, is voluntarily recalling one lot of Hydrochlorothiazide Tablets 25 mg 1000-count bottle at the consumer level, US Food and Drug Administration (USFDA) said in a statement.
Vodafone Business Services (VBS) collaborate with Diabetacare to launch dCare Smart, a device that helps people manage diabetes better. The device transmits blood sugar results to a secure Diabetacare server, where they are constantly monitored by diabetes specialist clinicians at the Diabetacare’s Diabetes Management Centre (DMC). dCare Smart is paired with the back-end clinical servers which connect directly to the electronic medical record system, wherein access is given to patients and their caregivers to keep them informed and better manage the condition.
Biocon’s novel drug pipeline which has an ophthalmology molecule, QPI-1007, is entering clinical trial phase. QPI-1007 is for ocular neuroprotection in NAION and acute angle closure glaucoma. In mid-December 2013, the company entered into a licensing and collaboration agreement for the development of a range of siRNA (small interfering RNA) based novel therapeutics with Quark Pharmaceuticals which was researching on QPI-1007.
USFDA rejected Sun Pharma Advanced Research Company’s Application for its new anti-glaucoma eye drops. The product is to be manufactured at Sun Pharmaceutical Industries’ Halol facility. USFDA has indicated that a satisfactory resolution of the current good manufacturing practice (cGMP) deficiencies at this facility is a prerequisite for the final approval of Xelpros.
CLICK HERE TO SUBSCRIBE,
PHARMATUTOR's DAILY EMAILS
Do Not Forget to Verify
(Click on Subscription link in your inbox)
--------
