PDS Biotechnology has secured fast track designation to its PDS0101 in combination with Merck’s KEYTRUDA (pembrolizumab) from the US Food and Drug Administration (FDA) for the treatment of HPV16-positive head and neck cancer that is recurrent or metastatic. The US-based clinical-stage immunotherapy company is currently evaluating the combination of PDS0101 and KEYTRUDA in the VERSATILE-002 […]
Merck will expand its membrane and filtration manufacturing capabilities in Ireland with an investment of around €440 million. The pharma giant will use the investment to ramp up its membrane manufacturing capacity in Carrigtwohill as well as construct a new manufacturing plant at Blarney Business Park in Cork. By the end of 2027, Merck’s latest […]
Pharma giant Merck has signed an all-cash deal worth around $780 million to acquire Exelead, an Indiana-based biopharmaceutical contract development and manufacturing organization (biopharma CDMO). Exelead is said to have specialization in complex injectable formulations, which include Lipid Nanoparticle (LNP) based drug delivery technology. According to Merck, LNP-based technology is important in mRNA therapeutics for […]
Aurobindo Pharma has secured consent from the Drugs Controller General of India (DCGI) for manufacturing and distributing its generic version of Covid drug Molnupiravir under the brand name — Molnaflu. The Indian pharma company had previously acquired the licensing rights for the generic version of MSD and Ridgeback Biotherapeutics’ Molnupiravir. A non-exclusive voluntary licensing agreement […]
Zydus Cadila said that its subsidiary has been granted tentative approval from the US Food and Drug Administration (FDA) for its new drug application (NDA) for Sitagliptin base 25, 50, and 100 mg tablets. The Indian pharma company said that Sitagliptin base has the active moiety Sitagliptin in a different form than the one used […]
Unichem Laboratories Limited said that it has secured tentative approval for abbreviated new drug application (ANDA) of Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg from the US Food and Drug Administration (FDA). The company’s Sitagliptin Tablets is a generic version of Januvia (sitagliptin) tablets, 25 mg, 50 mg, and 100 mg, of […]
Five Indian pharma companies – Cipla, Dr. Reddy’s Laboratories, Emcure Pharmaceuticals, Sun Pharmaceutical Industries, and Torrent Pharmaceuticals will join forces to undertake a clinical trial of Molnupiravir, an investigational oral anti-viral drug for the treatment of mild Covid-19 in India. The clinical trial of Molnupiravir will be in an outpatient setting. Molnupiravir is being developed […]
Divi’s Laboratories Limited has been selected by pharma giant MSD (known as Merck in the US and Canada) as an authorized manufacturer for the active pharmaceutical ingredient (API) of the latter Covid-19 drug candidate Molnupiravir. The Hyderabad-based API producer said that it is allowed to supply Molnupiravir API to MSD’s Currently, Molnupiravir is being evaluated […]
Dr. Reddy’s Laboratories has launched Ertapenem for Injection, 1 g/vial, a generic version of INVANZ (ertapenem for injection) for injection, 1 g/vial, which has approval from the US Food and Drug Administration (FDA) for the treatment of various bacterial infections. The Indian pharma company has extended its partnership with Gland Pharma to launch Ertapenem for […]
Cipla has entered into a non-exclusive licensing agreement with MSD (called Merck in the US and Canada) for the manufacturing and distribution of Molnupiravir (EIDD-2801/MK-4482), an investigational oral antiviral drug for the treatment of Covid-19 in patients who are not hospitalized. Molnupiravir is currently being assessed in a phase 3 trial. It is being developed […]