Lupin launches Leflunomide Tablets USP
These tablets are indicated for the treatment of adults with active rheumatoid arthritis
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BiomX collaborates with Boehringer Ingelheim for microbiome-based biomarkers for IBD
The terms of the collaboration also include an option for Boehringer Ingelheim to negotiate an exclusive right to biomarkers…
US FDA issues warning to Mylan for Telangana plant
It has also recommended the company to engage a cGMP Consultant
US FDA releases guidance to detect and prevent nitrosamines in drugs
It recommends steps, including a comprehensive risk assessment strategy and other actions
Zydus Cadila gets US FDA approval for Cisatracurium Besylate Injection
It is a nondepolarising skeletal neuromuscular blocker for intravenous administration
US FDA approves Onureg (azacitidine tablets) to treat acute myeloid leukaemia
AML is one of the most common acute leukaemias in adults
Plans to revamp D&C Act 1940, launch Sugam portal Version II: Dr Eswara Reddy
The CDSCO is also making a list of government facilities for R&D and innovation and will be making it available on their…
67 per cent experts to use decentralised clinical trials in near future due to COVID-19: GlobalData
Majority of respondents also consider the cost of decentralised clinical trials to be lower than that of traditional trials
INmune Bio gets US FDA nod for Phase II trial of Quellor, a sTNF inhibitor for COVID-19 treatment
Trial to evaluate the efficacy of Quellor to blunt the cytokine storm and decrease the catastrophic complications of COVID-19…
Gilead and Jounce Therapeutics sign exclusive license pact for novel immunotherapy program
Jounce will lead the development of JTX-1811 through IND clearance, and thereafter, Gilead will have the sole right to develop…
EU approves AstraZeneca’s Imfinzi for treatment of extensive-stage small cell lung cancer
Imfinzi, in combination with etoposide and either carboplatin or cisplatin, is also approved in the US, Japan and several other…
Novavax and Canada reach agreement in principle for 76 mn doses of COVID-19 vaccine
NVX-CoV2373 is currently in multiple Phase 2 clinical trials
Phase III trials of AstraZeneca COVID-19 vaccine candidate begins in US
AZD1222 is already undergoing late-stage clinical trials in Britain, Brazil and South Africa, with additional trials planned in…
GSK, Vir Biotech to test COVID-19 antibody treatment
The long-acting single injection will be tested on recently diagnosed high-risk cases for its ability to prevent hospitalisation
Only drug inspectors can probe, file FIRs for certain cognizable offences under D&C Act 1940:…
Industry experts and regulators appreciate judgement but seek clear SOPs for implementation
Nestlé to acquire biopharma company, Aimmune Therapeutics
Aimmune's Palforzia is an FDA-approved treatment to help reduce the frequency and severity of allergic reaction to peanuts
Agilent supports customer laboratories at every step: Sandeep Tandon
Sandeep Tandon, Sales Director, Services and Support Division & LSS India, Strategic Customer Programme, Agilent Technologies…
US FDA willing to give EUA for COVID-19 vaccines before Phase III trials
FDA Commissioner also said that it is not a blanket approval and will be subject to benefits outweighing the risks
Biocon Biologics and Mylan launch Semglee (insulin glargine injection) in US
Mylan is offering Semglee at a wholesale acquisition cost (WAC) of $147.98 per package of five 3ml pens and $98.65 per 10ml vial
Diabetes drug, Dapagliflozin shows benefits in patients with CKD
The drug, on top of standard of care, reduced the composite measure of worsening of renal function or risk of cardiovascular (CV)…