Biocon Biologics India, a subsidiary of India’s Biocon, has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration for the Pre-Approval Inspection (PAI) at two of its biologics manufacturing facilities in Bengaluru. 16 April 2020
Australian drugmaker Mayne Pharma closed trading today up 11.6% at A$0.385, after saying it has submitted a New Drug Application (NDA) to the US Food and Drug Administration, seeking marketing authorization for E4/DRSP, a combined oral contraceptive indicated for the prevention of pregnancy. 16 April 2020
According to the latest news from Science and Technology Daily (April 14), two COVID-19 inactivated vaccines were just approved for a Phase I & II combined clinical trial by China’s National Medical Products Administration (NMPA), making them the first batch in this category. 16 April 2020
The Food and Drug Administration late yesterday granted expedited approval for Jelmyto (mitomycin) for pyelocalyceal solution, a first-in-class treatment indicated for adults with low-grade upper tract urothelial cancer (LG UTUC). 16 April 2020
China recently issued the amended version of drug registration regulation, effective on July 1, reports The Pharma Letter’s local correspondent Wang Fangqing. 14 April 2020
Kolon Life Science has announced that the clinical hold issued by the US Food and Drug Administration in April 2019 has been lifted effective April 10, 2020, and that the company can continue with its knee osteoarthritis (OA) Phase III clinical trial of Invossa (TG-C). 14 April 2020
A Supplementary Protection Certificate (SPC) is an extremely valuable prize for the pharmaceutical patent owner as it extends the patent life of an authorised medicine for up to five years at a time when a successful drug is likely to be well established and at the top of its earning power. 14 April 2020
The Association of International Pharmaceutical Manufacturers (AIPM), uniting more than 60 leading world pharmaceutical companies in Russia, says it is doing everything possible to coordinate the efforts of the industry and support the state in combating the COVID-19 pandemic. 13 April 2020
The US Food and Drug Administration on Friday approved Koselugo (selumetinib) for the treatment of pediatric patients, two years of age and older, with neurofibromatosis type 1 (NF1), a genetic disorder of the nervous system causing tumors to grow on nerves. 11 April 2020
The Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Braftovi (encorafenib) from Array BioPharma, which was acquired last July by Pfizer in an $11.4 billion deal. 10 April 2020
The leading trade group representing the European pharma industry has released guidance on managing clinical trials under the changing circumstances brought about by the COVID-19 pandemic. 9 April 2020
Germany’s Merck KGaA and US pharma giant Pfizer today announced completion of the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration for Bavencio (avelumab) for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC). 9 April 2020
Indian generic drugs major Cipla has received final approval for its Abbreviated New Drug Application (ANDA) for albuterol sulfate Inhalation aerosol 90mcg from the US Food and Drug Administration. 9 April 2020
Swiss oncology giant Roche has announced an extension to the US review of its risdiplam New Drug Application (NDA) in spinal muscular atrophy (SMA). 8 April 2020
Among several actions take this week in in its ongoing response effort to the COVID-19 pandemic, the Food and Drug Administration approved an Abbreviated New Drug Application (ANDA) for Hydroxychloroquine Sulfate Tablets USP, 200mg. for the treatment of: 8 April 2020
Global regulators are discussing how data generated during clinical practice could “complement evidence” from clinical trials in COVID-19. 7 April 2020
US RNAi therapeutics company Alnylam Pharmaceuticals has announced the completion of the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase (GO), in development for the treatment of primary hyperoxaluria type 1 (PH1). 7 April 2020
Following a positive opinion from the European Medicines Agency’s advisory body the CHMP in late February, Japanese pharma giant Takeda today announced that the European Commission has extended the current marketing authorization of Alunbrig (brigatinib). 6 April 2020
The European Commission has conditionally approved the marketing application submitted by Ipsen for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) 21 September 2024
On Friday, the US Food and Drug Administration approved UK pharma major AstraZeneca’s (LSE: AZN) FluMist for self- or caregiver-administration by a parent/caregiver to individuals 2-17 years of age. 21 September 2024
Today, the US Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). 20 September 2024
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) recommended approval of five novel medicines at its September meeting 20 September 2024
The Israeli Ministry of Health (IL MOH) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC). 20 September 2024
The European Medicines Agency’s (EMA) advisory committee the CHMP has adopted a positive opinion for a label update of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide 2.4mg). 20 September 2024
Vanda Pharmaceuticals’ shares were down more than 10% at $4.45 pre-market today, as the) company provided an unfavorable update on its tradipitant development program. 19 September 2024
Applied Therapeutics saw its stock price climb by over two-thirds after an encouraging update on the US Food and Drug Administration review of govorestat. 19 September 2024
Pharma giant Merck & Co has announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), alongside pemetrexed and platinum chemotherapy, for the first-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). 18 September 2024
AstraZeneca’s Fasenra (benralizumab) has been approved in the USA for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA, the UK pharma major announced today. 18 September 2024
Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024
Bayer has submitted a Marketing Authorization Application (MAA) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the investigational compound elinzanetant. 17 September 2024
The US Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), from Swiss pharma giant Roche. 16 September 2024
The Gastrointestinal Drugs Advisory Committee (GIDAC) of the US Food and Drug Administration (FDA) met on Friday to discuss Intercept Pharmaceuticals’ supplemental New Drug Application (sNDA) for Ocaliva (obeticholic acid, OCA). 16 September 2024
Oligonucleotide therapeutics are rapidly emerging as a promising class of drugs capable of addressing a variety of genetic and complex diseases by targeting RNA sequences.1 16 September 2024
On Thursday, the US Food and Drug Administration released a Drug Safety Communication warning that Veozah (fezolinetant), which is used to treat hot flashes due to menopause, can cause rare but serious liver injury. 13 September 2024
The US Food and Drug Administration (FDA) has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC) injection for patients in the USA, Swiss pharma giant Roche subsidiary Genentech announced yesterday. 13 September 2024