Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 64
Drug Approval
Drug Approval | 24 September 2021

Zydus Cadila receives final approval for Apremilast

Zydus' Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy

Drug Approval
Drug Approval | 23 September 2021

Pfizer and BioNTech receive U.S. FDA EUA for Covid-19 booster

Emergency Use Authorisation (EUA) is granted for individuals 65 years of age and older, and individuals ages 18 through 64 within certain high-risk groups

Drug Approval
Drug Approval | 21 September 2021

U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar

It becomes the first ophthalmology biosimilar to gain FDA approval in the United States

Drug Approval
Drug Approval | 21 September 2021

Glenmark receives ANDA approval for treatment of acne

Clindamycin Phosphate Foam, 1% is the generic version of Evoclin Foam, 1%

Drug Approval
Drug Approval | 21 September 2021

Lincoln Pharma plans to launch Cephalosporin product portfolio soon

Cephalosporin is a bactericidal, broad-spectrum, and P-lactam antibiotic originally derived from the fungus Acremonium, which is used to treat bacterial infections such as pneumonia, skin infections, ear infection, strep throat, staph infections, tonsillitis, bronchitis among others

Drug Approval
Drug Approval | 20 September 2021

Novartis’ Kisqali data indicates longest median survival in advanced breast cancer

With the MONALEESA-2 final analysis, only Kisqali has reported statistically significant overall survival (OS) benefit with an aromatase inhibitor for postmenopausal women with HR+/HER2- advanced breast cancer in the first-line (1L) setting

Drug Approval
Drug Approval | 18 September 2021

Roche receives positive CHMP opinion for Gavreto

If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC

Drug Approval
Drug Approval | 18 September 2021

BMS receives positive CHMP opinion for Opdivo

The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy

Drug Approval
Drug Approval | 18 September 2021

Zydus Cadila receives final nod for anti-depressant

The medicine helps restore the balance of certain natural substances (serotonin) in the brain

Drug Approval
Drug Approval | 17 September 2021

Canada approves Moderna’s Covid-19 vaccine

In the final analysis of Phase 3 COVE study data, SPIKEVAX showed 93% efficacy, with the efficacy remaining durable through six months after the administration of the second dose

Drug Approval
Drug Approval | 16 September 2021

Lancet study confirms Johnson & Johnson Ebola vaccine safe

Data show the vaccine regimen induced neutralising antibody responses in nearly all participating adults and children 21 days after the second dose. Adults receiving booster shots two years after the initial vaccination regimen showed strong immune responses

Drug Approval
Drug Approval | 15 September 2021

Lupin launch a generic version of pain reliever for osteoarthritis in the US

Ibuprofen and Famotidine tablets (Duexise) had estimated annual sales of US $ 765 million in the US as if July 21

Drug Approval
Drug Approval | 15 September 2021

Serum Institute to supply polio vaccine for India’s universal immunisation plan

The first lot of IPV will be supplied to the government this month as per the requirement of the Health Ministry

Drug Approval
Drug Approval | 14 September 2021

BDR Pharmaceuticals launch Cabozantinib to treat thyroid cancer

In several trials like Celestial (double-blind phase III trial), Phase III Meteor trials, Cabozantinib has shown better PFS (Progression-Free Survival).

Drug Approval
Drug Approval | 12 September 2021

US FDA grants Soligenix Orphan Drug Designation for the treatment of T-cell lymphoma

Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma

Drug Approval
Drug Approval | 09 September 2021

Zydus Cadila gets US FDA approval for antidepressant tablets

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.

Drug Approval
Drug Approval | 09 September 2021

Merck’s KEYTRUDA receives China approval for Esophageal cancer

The medicine is now approved for eight indications across five different types of cancer in China.

Drug Approval
Drug Approval | 09 September 2021

Sandoz enters agreement for oncology biosimilar medicine bevacizumab

Sandoz is committed to building on its leading generic and biosimilar oncology portfolio to further expand patient access while contributing to the sustainability of healthcare systems

Drug Approval
Drug Approval | 07 September 2021

Sharp develops Plasmacluster tech that reduces airborne novel coronavirus

Plasmacluster technology significantly inactivates SARS-CoV-2 contained in adherent saliva in an environment with 60% humidity where the physiological protective function is maintained

Drug Approval
Drug Approval | 07 September 2021

Dr Reddy’s launches Minoxidil for women

It is the first-ever approval in India for the treatment of Female Pattern Hair Loss (FPHL) and will be available only on prescription by a dermatologist

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