Pharma News

Targeting FGFR has recently emerged as a promising strategy in the treatment of cholangiocarcinoma (CCA), a very aggressive rare malignancy. At ESMO Congress 2022, two new agents were added to the list of FGFR inhibitors being investigated, showing some clinical benefits or potential in patients not previously treated with this anticancer drug class.

Two early studies investigate the anticancer activity of derazantinib and RLY-4008 in patients with FGFR inhibitor-naive cholangiocarcinoma.

The USFDA rejected Alvotech’s application to approve its biosimilar of AbbVie’s Humira after an inspection of the company’s Reykjavik, Iceland, manufacturing plant.

Alvotech received communication from the U.S. Food and Drug Administration (USFDA) detailing its assessment of the March 2022 inspection of Alvotech’s manufacturing facility in Reykjavik, Iceland and Alvotech’s subsequent written responses to the FDA.

ICMR-National Institute of Malaria Research scientists from India published an opinion in Lancet Regional Health Southeast Asia that India requires Artificial Intelligence (AI) based approaches into the current microscopy method for detection of Malaria.

Indian Pharmacopoeia commission (IPC) to add 8 chemical monographs and 7 Veterinary Monographs and open them for Public Review and Comments.

IPC to add chemical monographs which include, Aceclofenac and paracetamol Tablets, Azacitidine for Injection, Ethamsylate, Lactulose Solution, Atropine Ophthalmic solution, Moxifloxacin Tablets, Remogliflozin Etabonate and Remogliflozin Tablets.

Global pharma major Lupin Limited announced the launch of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ounces, having received an approval from the United States Food and Drug Administration (FDA).

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ounces is a generic equivalent of Suprep Bowel Prep Kit Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ounces, of Braintree Laboratories Inc.

Zydus Lifesciences Ltd., an innovation-driven global life sciences announced that it has acquired rights to market MonoFerric  (iron isomaltoside) injections in India and Nepal from Denmark based Pharmacosmos A/S. MonoFerric , iron isomaltoside 1000 solution for injection/infusion, is a rapid, single dose IV iron (up to 20 mg/kg bodyweight) developed to reduce the number of infusions required to achieve iron correction with an excellent safety profile.

Indian Pharmaceutical Alliance (IPA) gives clean chit to Micro Labs, Dolo maker, against a case on Rs. 1,000 crores in freebies to doctors, and states that the company is following the processes as per the Uniform Code of Pharmaceutical Marketing Practices, UCPMP, guidelines.

Novartis announced the results from two pivotal, Phase III studies, in which Cosentyx (secukinumab) demonstrated rapid and sustained relief from the common clinical signs and symptoms of moderate-to-severe hidradenitis suppurativa (HS) with a favorable safety profile.

The data were presented as a late-breaking abstract at the 31st European Academy of Dermatology and Venereology (EADV) Congress.

​U.S. Food and Drug Administration (FDA) is alerting health care providers about potential clip lock malfunctions with MitraClip Delivery Systems manufactured by Abbott.

An increased rate of reports of clip lock malfunctions has been observed before and after clip deployment. These events appear to occur in approximately 1.3% of MitraClip procedures and have been observed with all device models, said Abbott.