Industry News

Bristol Myers Squibb announced new two-year results from the POETYK PSO long-term extension (LTE) trial demonstrating clinical efficacy was maintained with continuous Sotyktu™ (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. This analysis assessed patients from the pivotal POETYK PSO-1 trial who transitioned into the LTE trial.

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.

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.

Cipla and Dr Reddys Lab receives FDA nod for marketing of generic version of REVLIMID (lenalidomide) Capsules. Both companies have received final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules.

With this volume-limited launch, Dr. Reddy’s Lab is eligible for first-to- market, 180 days of generic drug exclusivity for Lenalidomide Capsules in 2.5 mg and 20 mg strengths.

AstraZeneca’s Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in China to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death and hospitalisation for heart failure (hHF) in adults with chronic kidney disease (CKD) at risk of progression with and without type-2 diabetes (T2D).