Pharma News

The U.S. Food and Drug Administration has approved the first generic of Restasis (cyclosporine ophthalmic emulsion) 0.05% single-use vials (eye drops) to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (commonly known as dry eye). Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.

Nuvaxovid, the COVID-19 vaccine developed by Novavax, has today been given regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA).  Nuvaxovid becomes the fifth COVID-19 vaccine authorised by the UK’s independent medicines regulator.

Central Drug Research Institute (CDRI) provides exclusive licensing to Aveta Biomics, USA of its patented technology of Caviunin-based drug compositions for further clinical development and commercialization.

Worldwide, one in three women and one in five men over the age of 50 years will suffer an osteoporotic fracture. In the US alone, an estimated 10 million people over the age of 50 years have osteoporosis and one in two women in the United States will sustain a fragility fracture in her lifetime.

Vasopressin and glucocorticoids compared to placebo, improved return of spontaneous circulation among adults for in-hospital cardiac arrest, says recent findings in Resuscitation.

The Health Ministry says that Acitretin will be included in Schedule H after making an amendment in the Drugs Rules, 1945. Acitretin is an oral retinoid used in the treatment of severe resistant psoriasis.

Schedule H is a class of prescription drugs in India appearing as an appendix to the Drugs and Cosmetics Rules, 1945. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor. The manufacture and sales of all drugs are covered under the Drugs and Cosmetics Act and Rules.

GlaxoSmithKline plc announced that ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi & Co. Limited Shionogi as shareholders, has agreed to settle the global patent infringement litigation between GSK, Shionogi and Gilead Sciences, Inc. Gilead concerning ViiV Healthcares patents relating to dolutegravir, an antiretroviral medication used, together with other medicines, to treat human immunodeficiency virus.

Pfizer Inc and BioNTech SE announced that following a request from the U.S. Food and Drug Administration the companies have initiated a rolling submission seeking to amend the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age 6 months to <5 years of age, in response to the urgent public health need in this population. The companies expect to complete the EUA submission in the coming days.

Alembic Pharmaceuticals Limited announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fesoterodine Fumarate Extended- Release Tablets, 4 mg and 8 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Toviaz Extended-Release Tablets, 4 mg and 8 mg, of Pfizer Inc. (Pfizer).

The clinical and imaging characteristics of COVID-19 breakthrough infections in fully vaccinated patients tend to be milder than those of partially vaccinated or unvaccinated patients, according to a new multicenter study published in the journal Radiology.

The number of confirmed COVID-19 cases worldwide now exceeds 270 million with an overall mortality rate of approximately 2%.