AstraZeneca: India's vaccine effort slows as dose gap trumps output jump

 India's vaccination campaign has slowed despite amassing record stockpiles of vaccine, health ministry data showed on Monday, as authorities maintain a wider-than-usual gap between doses in a strategy that has boosted coverage.

Domestic production of the AstraZeneca vaccine, which accounts for nearly 90% of administered doses, has more than tripled https://www.reuters.com/world/india/india-resumes-vaccine-exports-domestic-stocks-build-up-officials-2021-10-13 since May, when a supply shortage prompted India to double the period between doses to between 12 and 16 weeks.

That gap, exceeding the 8 to 12 weeks recommended by the World Health Organization, has allowed India to give at least one vaccine dose to 74% of its 944 million adults, with just 30% getting the full complement of two.

The AstraZeneca vaccine, known as Covishield, accounts for 861 million doses of India's total injected figure of 977.6 million, while its other main vaccine, Covaxin has a dose interval of four to six weeks.

Over the last few days, daily stocks of all COVID-19 vaccines have exceeded 100 million doses, the health ministry figures show, for states and federally controlled territories taken together.

In contrast, daily vaccinations have dropped to an average of 5 million doses this month and even less in the past week, off a daily peak of 25 million last month.

The ministry said it followed recommendations from a group of experts in making any changes to dosage, arrived at by weighing up "scientific and empirical" evidence.

"NTAGI is actively considering the matter of dose interval between Covishield doses," its spokesperson told Reuters, referring to the ministry's National Technical Advisory Group on Immunisation (NTAGI).

However, vaccine supply alone should not determine the gap, said Chandrakant Lahariya, a physician and epidemiologist in the capital, New Delhi.

"There is no scientific rationale for reducing the gap," he added. "In fact, retaining this gap has the possibility of giving stronger protection and longer-lasting immunity."

Government officials have said they are trying to encourage more of those who are still unvaccinated to get inoculated.

A 12-week gap was more logical and scientific for vaccinations drives such as those in India, where some studies have shown many people already had antibodies against COVID-19, Lahariya said.

In July, the studies estimated that more than two-thirds of Indians already had COVID-fighting antibodies, mainly through natural infection.

Monday's 13,596 new cases were India's lowest rise in 230 days, taking its tally of infections past 34 million. Deaths rose by 166 to stand at 452,290.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-India-s-vaccine-effort-slows-as-dose-gap-trumps-output-jump-36704212/

Gilead: FDA OKs Expanded Indication of Biktarvy in Pediatrics

 Gilead Sciences Inc. said the U.S. Food and Drug Administration approved an expanded indication of its Biktarvy for treatment of HIV-1 in pediatric populations.

Gilead said the FDA approved a new low-dose tablet dosage form of Biktarvy for pediatric patients weighing at least 14 kilograms to less than 25 kg who are virologically suppressed or new to antiretroviral therapy.

The approval expands the indication for Biktarvy to include younger children living with HIV-1 infection and will help to close the gap between HIV treatment options available for adults and children, the company said.

The new approval of Biktarvy is based on data from cohort three of a Phase 2/3 open-label, single-arm study which found Biktarvy low-dose tablets to be effective and generally well-tolerated through 24 weeks in virologically suppressed children living with HIV-1.

"Children living with HIV are in need of effective and accessible formulations of antiretroviral therapy," said Chief Medical Officer Merdad Parsey. "To address this unmet need, innovations in pediatric formulations must strive towards expanding treatment options for children."

https://www.marketscreener.com/quote/stock/GILEAD-SCIENCES-INC-4876/news/Gilead-Says-FDA-Approves-Expanded-Indication-of-Biktarvy-for-Treatment-of-HIV-1-in-Pediatric-Populat-36707404/

Oyster Point Pharma med 1st FDA-approved nasal spray to treat dry eyes

 Oyster Point Pharma Inc's treatment for dry eye disease became the first U.S. approved nasal spray for the chronic condition, sending the drug developer's shares about 7% higher in morning trade.

The company said on Monday its spray, Tyrvaya, will be made available from next month to patients with a prescription, but did not reveal its listing price.

Tyrvaya's potential market size could be more than $1 billion, Cowen and Co analyst Ken Cacciatore said in a note, as the market is still large and underserved.

The dry eye disease -- characterized by stinging, sensitivity to light, blurred vision and eye fatigue -- affects about 38 million Americans, and is currently treated with over-the-counter artificial tear drops such as GenTeal and Refresh.

Oyster Point Chief Commercial Officer John Snisarenko said Tyrvaya will be "very affordable and competitive" with Novartis' Xiidra and AbbVie Inc's Restasis -- prescription eye drops also used to treat dry eye disease.

He said patients will have to pay around $10 out of pocket for Tyrvaya if their insurers do not cover the drug.

Oyster Point said the twice daily nasal spray was tested in trials covering over 1,000 patients with mild, moderate or severe symptoms, where it showed statistically significant improvement in production of tear film on eye surface.

Tear film helps keep eyes moist, reducing risks of infection and contributing to clear vision.

Tyrvaya, the first approved product for Oyster Point, is significantly differentiated from competition due to its faster onset of action, impressive safety and tolerability profile, and ease of use, Cacciatore said.

It is a nasal spray formulation of the drug varenicline, also used in Pfizer Inc's smoking cessation drug, Chantix.

https://www.marketscreener.com/quote/stock/OYSTER-POINT-PHARMA-INC-71598394/news/Oyster-Point-Pharma-drug-becomes-first-FDA-approved-nasal-spray-to-treat-dry-eyes-36706443/

Avidity Biosciences Lead Program Gets FDA Fast-Track

 Avidity Biosciences Inc. on Monday said the U.S. Food and Drug Administration granted fast-track designation to AOC 1001, its lead program, for the genetic multisystem disorder myotonic dystrophy type 1.

The biopharmaceutical company said there are currently no approved treatments for the progressive and often fatal disease, which primarily affects skeletal and cardiac muscle.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

The FDA previously cleared Avidity to proceed with a Phase 1/2 study of AOC 1001 in adults with myotonic dystrophy type 1.

https://www.marketscreener.com/quote/stock/AVIDITY-BIOSCIENCES-INC-108225209/news/Avidity-Biosciences-Lead-Program-Gets-FDA-Fast-Track-Designation-36708547/

Molecular Templates: Vertex Terminates Collaboration

 Molecular Templates Inc. on Monday said Vertex Pharmaceuticals Inc. is terminating a 2019 collaboration aimed at developing conditioning agents for applications aimed at enhancing the hematopoietic stem cell transplant process.

Molecular, an Austin, Texas, clinical-stage biopharmaceutical company, said the termination is effective Oct. 29.

Under the 2019 agreement, Boston drug maker Vertex made a $38 million upfront payment to Molecular, which was also eligible for future milestone and option payments of up to $522 million.

As part of the collaboration, Molecular was developing engineered toxin bodies for myeloablation, an indication separate from its core focus on cancer therapeutics.

https://www.marketscreener.com/quote/stock/MOLECULAR-TEMPLATES-INC-37318006/news/Molecular-Templates-Vertex-Terminates-Collaboration-36709041/

GSK - NEW PHASE 3 DATA FOR DAPRODUSTAT ON POTENTIAL TREATMENT FOR ANAEMIA

 GSK - NEW PHASE 3 DATA FOR DAPRODUSTAT ON POTENTIAL TREATMENT FOR PATIENTS WITH ANAEMIA DUE TO CHRONIC KIDNEY DISEASE IN DIALYSIS, NON-DIALYSIS PEOPLE

https://www.marketscreener.com/news/latest/GSK-NEW-PHASE-3-DATA-FOR-DAPRODUSTAT-ON-POTENTIAL-TREATMENT-FOR-PATIENTS-WITH-ANAEMIA-DUE-TO-CHRON--36710477/

Medtronic Stock Plunges On Reports of Recall Expansion

Medtronic PLC (NYSE:MDT) stock is sliding Monday after a report from New York Injury Law News said that a recent recall of Medtronic Pipeline Embolization Devices has been expanded.

Shares fell 5.11% in morning trading.

The previous recall included around 800 devices. The report said it has now been expanded to include approximately 8,825, with Medtronic asking healthcare providers to immediately return unused products and contact Medtronic.

The device is a braided wire mesh tube that is flexible and placed within the affected artery to treat and prevent certain brain aneurysms.

According to New York Injury Law News, Medtronic is making the recall because of a risk that the delivery system’s wire and tubes may fracture or break while the doctor is putting it in place.

If the device breaks, pieces could be left inside the patient's bloodstream and cause additional health problems. The recall has been identified as Class I, meaning it could cause severe injury or fatality.

Earlier this month, the FDA issued a Class I recall on Medtronic's MiniMed Remote Controllers used with a Medtronic MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps. 

https://finance.yahoo.com/news/medtronic-stock-plunges-reports-recall-105603299.html