News

Russian biotechnology company BIOCAD and Moroccan pharmaceutical company Sothema Labs announced the launch of medicines derived using the technology provided by the Russian manufacturer…
Read More...

Certara announced that the US Food and Drug Administration (FDA) has greatly expanded its use of Certara’s PBPK Simcyp® Population-based Simulator and its Pediatric and Cardiac Safety…
Read More...

Sobi has received approval from Health Canada for an oral suspension formulation of Orfadin® (nitisinone). Orfadin is the first medicine approved in multiple countries globally for use…
Read More...

Biogen and Alkermes plc announced that they have entered into a global license and collaboration agreement to develop and commercialize ALKS 8700, a novel, oral, monomethyl fumarate…
Read More...

AstraZeneca announced the submission of a supplemental new drug application (sNDA) to Japan’s Pharmaceuticals and Medical Devices Agency for the use of Tagrisso (osimertinib), a…
Read More...

Takeda Pharmaceutical announced that its purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate (TAK-426) has progressed into a Phase 1 clinical trial, approximately…
Read More...

Pharming Group announced that it has submitted a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration for RUCONEST  for routine prophylaxis to…
Read More...

HitGen Ltd announced that the company has entered into a drug discovery research collaboration with Boehringer Ingelheim to identify novel small molecule leads for targets of interest…
Read More...

Brammer Bio announced the completion of renovations and launch of its late-stage clinical capacity and commercial-ready cGMP manufacturing site in Cambridge, Massachusetts for gene…
Read More...

Recipharm has equipped three more of its facilities with serialisation capabilities in line with the US regulatory requirements in time for today’s introduction of the Drug Supply Chain…
Read More...

Catalyst Pharmaceuticals announced positive top-line results from a second Phase 3 clinical trial (LMS-003) of Firdapse® (amifampridine phosphate tablets equivalent to 10 mg…
Read More...

Stealth BioTherapeutics (Stealth) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead candidate, elamipretide, for the treatment…
Read More...

Lead Pharma announced that it has achieved a third milestone under its research collaboration with Sanofi, triggering an undisclosed milestone payment. The collaboration aims to develop…
Read More...

Beactica, the Swedish drug discovery company, announced that it has been awarded 2 MSEK (~$240 000) by the Swedish Governmental Agency for Innovation Systems (Vinnova) to advance its…
Read More...

Fresenius Kabi, a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition, will expand its manufacturing operations in…
Read More...

Systech International and NKP Pharma announced a strategic agreement. The accord allows the two companies to provide software/hardware solutions to the Indian pharmaceutical industry…
Read More...

KMT Hepatech announced that it has reached an agreement to join efforts with PhoenixBio Co., Ltd. (PhoenixBio). Together they will advance the use of the cDNA-uPA/SCID mouse model with…
Read More...

MariMed client Kind Therapeutics USA LLC (Kind) has successfully passed the Maryland Cannabis Commission compliance inspection of its newly renovated facility designed and developed by…
Read More...

Orexo AB (publ.) announce that the European Medicines Agency (EMA) has granted a Marketing Authorization (MA) for Zubsolv (buprenorphine and naloxone), a novel rapidly-disintegrating…
Read More...

Novartis, the American Society for Clinical Pathology (ASCP) and the American Cancer Society (ACS) announced that they will work together to devise a common approach to improve access…
Read More...