The U.S. Is Facing Shortages in COVID-19 Drugs as Omicron Rages
Two brand-new COVID-19 pills that were supposed to be an important weapon against the pandemic in the U.S. are in short supply and have played little role in the fight against the Omicron wave of infections. The problem is that production is not yet at full strength and that the pill considered to be far superior, Pfizer’s, takes six to eight months to manufacture. While the supply is expected to improve dramatically in the coming months, doctors are clamoring for the pills now, not just because Omicron is causing an explosion of cases but because two antibody drugs that were once the go-to treatments don’t wor...
Source: TIME: Health - January 13, 2022 Category: Consumer Health News Authors: MATTHEW PERRONE/AP Tags: Uncategorized COVID-19 Drugs healthscienceclimate wire Source Type: news

The Petri Dish: Merck names Cambridge site leader, HotSpot inks $40M+ deal
While some in the life sciences industry create drugs and devices to tackle the Covid-19 pandemic, their colleagues are busy as ever raising money, testing new drugs, expanding facilities and more. (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - January 13, 2022 Category: American Health Authors: Rowan Walrath Source Type: news

Merck says no safety concerns observed in molnupiravir phase-3 trial, shared relevant data with DCGI
Merck Sharp& Dohme (MSD) on Friday said its COVID antiviral molnupiravir has cut the risk of hospitalization or death in Phase 3 clinical trial with no observed safety concerns when compared to the placebo group. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 7, 2022 Category: Pharmaceuticals Source Type: news

CDC Director Rochelle Walensky Faces a Surging Virus —And a Crisis of Trust
If viruses know no borders, they
 have an equal disdain for human holidays. On Thanksgiving 2021, Dr. Rochelle Walensky shut off her phone for about 45 minutes and placed the turkey on the dining table to enjoy the holiday meal with her husband and three sons. When she turned the phone back on, she found, among the messages that had piled up, warnings that SARS-CoV-2 had morphed into a potentially dangerous new variant, identified in South Africa. Health officials there predicted that what would become known as the Omicron variant was much better at spreading than previous variants, and Walensky knew it was only a matter...
Source: TIME: Health - January 5, 2022 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized COVID-19 feature healthscienceclimate Magazine Source Type: news

Telix, Olivia Newton-John Cancer Research Institute to collaborate
Telix Pharmaceuticals plans to collaborate with the Olivia Newton-John Cance...Read more on AuntMinnie.comRelated Reading: Telix secures FDA clearance for prostate cancer PET imaging agent Telix applauds NCCN radiotracer update Telix, Kettering to research PSMA radiotracer Lightpoint, Telix ink collaboration agreement Telix works with Merck on cancer therapies (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - January 4, 2022 Category: Radiology Source Type: news

Covid cases on the rise, experts call for newer drugs, faster approvals
The Drug Controller General of India had last week approved Merck and Ridgeback ’s antiviral molnupiravir for the treatment of mild-to-moderate Covid-19 at high risk of developing into severe disease. (Source: The Economic Times)
Source: The Economic Times - January 2, 2022 Category: Consumer Health News Source Type: news

Monthly News Roundup - December 2021
Paxlovid and Molnupiravir: FDA Issues Two EUAs for Oral COVID-19 Treatments In December, two oral COVID-19 treatments were given FDA Emergency Use Authorization (EUA): Pfizer’s Paxlovid (nirmatrelvir and ritonavir) and Merck / Ridgeback... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - December 31, 2021 Category: Pharmaceuticals Source Type: news

Domestic pharma companies gear up to launch Merck's Covid pill
Union health minister Mansukh Mandaviya said 13 companies in India will manufacture the drug approved for restricted use under emergency situation for treatment of adult patients who have high risk of progression of Covid-19. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 29, 2021 Category: Pharmaceuticals Source Type: news

India boosts arsenal against COVID-19 with Merck pill, two more vaccines
India has approved Merck's COVID-19 pill and two more vaccines for emergency use as the world's second most populous country braces for a possible spike in coronavirus cases due to the rapidly... #merck #spike (Source: Reuters: Health)
Source: Reuters: Health - December 28, 2021 Category: Consumer Health News Source Type: news

Japan Health Panel Approves Merck's Oral COVID-19 Treatment Japan Health Panel Approves Merck's Oral COVID-19 Treatment
A Japanese health ministry panel recommended approval of the COVID-19 antiviral pill developed by Merck last week, part of plans by Prime Minister Fumio Kishida to roll out new treatments by year's end.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 27, 2021 Category: Consumer Health News Tags: Infectious Diseases News Source Type: news

FDA authorizes additional oral antiviral for treatment of COVID-19 in certain adults
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Merck's molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. (Source: World Pharma News)
Source: World Pharma News - December 27, 2021 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news

Experts panel to review applications of Covovax & Corbevax jabs; Merck's Covid drug today
The subject experts committee (SEC), a body under India's drug regulator, will meet on Monday to review the applications for granting approval to the new vaccines and the antiviral drug, people in the know told ET. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 27, 2021 Category: Pharmaceuticals Source Type: news

Govt panel weighing risks and benefits of Merck's Covid drug
The Subject Expert Committee (SEC) under the drug regulator of India has asked manufacturers in India to specify the category of Covid patients that are likely to receive the greatest benefit of the treatment from the drug be indicated. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 25, 2021 Category: Pharmaceuticals Source Type: news

FDA Gives OK to Merck Antiviral At - Home COVID - 19 Pill
Molnupiravir cut the risk for hospitalization and death in high - risk patients by 30 percent (Source: Pulmonary Medicine News - Doctors Lounge)
Source: Pulmonary Medicine News - Doctors Lounge - December 24, 2021 Category: Respiratory Medicine Tags: Family Medicine, Geriatrics, Infections, Internal Medicine, Emergency Medicine, Nursing, Pharmacy, Pulmonology, FDA Approvals, Source Type: news

FDA Gives OK to Merck Antiviral At-Home COVID-19 Pill
THURSDAY, Dec. 23, 2021 -- Many Americans now have two oral antiviral pills that can be taken at home to treat a fresh case of COVID-19. The U.S. Food and Drug Administration on Thursday approved the emergency use of the molnupiravir pill from Merck... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - December 23, 2021 Category: Pharmaceuticals Source Type: news

Merck ’s Covid Pill Is Authorized by F.D.A. for High-Risk Adults
The F.D.A. said the drug should be prescribed mainly when other treatments were “not accessible or clinically appropriate.” (Source: NYT Health)
Source: NYT Health - December 23, 2021 Category: Consumer Health News Authors: Rebecca Robbins and Carl Zimmer Tags: Merck & Company Inc Food and Drug Administration Pfizer Inc Coronavirus Omicron Variant Molnupiravir (Drug) Coronavirus (2019-nCoV) Drugs (Pharmaceuticals) Paxlovid (Drug) Source Type: news

US adds Merck pill as 2nd easy-to-use drug against COVID-19
U.S. regulators have authorized a second pill against COVID-19, an antiviral drug from Merck that may help blunt the wave of infections driven by the omicron variant (Source: ABC News: Health)
Source: ABC News: Health - December 23, 2021 Category: Consumer Health News Tags: Health Source Type: news

Coronavirus (COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults
The FDA issued an emergency use authorization for Merck ’s molnupiravir for the treatment of mild-to-moderate COVID-19 in certain adults. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - December 23, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

The FDA has authorized Merck's COVID pill for home use — the 2nd in 2 days
The medicine, called molnupiravir, is taken twice a day for five days and works by preventing the virus from replicating. Merck says it will have 10 million packs available by the end of the month.(Image credit: Merck & Co., Inc.) (Source: NPR Health and Science)
Source: NPR Health and Science - December 23, 2021 Category: Consumer Health News Authors: Scott Hensley Source Type: news

FDA OKs Emergency Use of Merck Pill for COVID-19
The authorization adds another antiviral pill for treating people with COVID-19, and comes the same week the FDA authorized a similar drug from Pfizer. (Source: WebMD Health)
Source: WebMD Health - December 23, 2021 Category: Consumer Health News Source Type: news

FDA Gives OK to Merck's Antiviral At-Home COVID Pill
THURSDAY, Dec. 23, 2021 -- Many Americans now have two oral antiviral pills that can be taken at home to treat a fresh case of COVID-19. The U.S. Food and Drug Administration on Thursday approved the emergency use of Merck's molnupiravir pill for... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - December 23, 2021 Category: General Medicine Source Type: news

FDA Grants Emergency Use for Merck's COVID-19 At-Home Antiviral Pill Molnupiravir
THURSDAY, Dec. 23, 2021 -- Many Americans now have two oral antiviral pills that can be taken at home to treat a fresh case of COVID-19. The U.S. Food and Drug Administration on Thursday approved the emergency use of Merck's molnupiravir pill for... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - December 23, 2021 Category: General Medicine Source Type: news

U.S. FDA Authorizes Merck ’s COVID-19 Pill, Despite Experts Questioning Its Value
U.S. health regulators on Thursday authorized the second pill against COVID-19, providing another easy-to-use medication to battle the rising tide of omicron infections. The Food and Drug Administration authorization comes one day after the agency cleared a competing drug from Pfizer. That pill is likely to become the first-choice treatment against the virus, thanks to its superior benefits and milder side effects. As a result, Merck’s pill is expected to have a smaller role against the pandemic than predicted just a few weeks ago. Its ability to head off severe COVID-19 is much smaller than initially announced and t...
Source: TIME: Health - December 23, 2021 Category: Consumer Health News Authors: MATTHEW PERRONE / AP Tags: Uncategorized COVID-19 healthscienceclimate wire Source Type: news

FDA authorizes a second antiviral to treat COVID-19, a Merck pill that can be taken at home: Updates
A day after authorizing the first antiviral pill to treat COVID-19, the FDA on Thursday authorized a second: Merck’s molnupiravir. Latest news. #merck (Source: Reuters: Health)
Source: Reuters: Health - December 23, 2021 Category: Consumer Health News Source Type: news

Regulators authorize second COVID-19 pill for US patients, a Merck drug that can be taken at home
(Source: ABC News: Health)
Source: ABC News: Health - December 23, 2021 Category: Consumer Health News Tags: Health Source Type: news

FDA issues emergency use authorization for second at-home COVID-19 treatment
For the second time in as many days, the Food and Drug Administration (FDA) has granted emergency use authorization for an investigational antiviral pill to treat COVID-19. This time it is Merck's molnupiravir. According to the company, under the emergency use authorization, the treatment is cleared to treat mild to moderate COVID-19 in adults who have tested positive for the disease, are at high risk for progression to severe COIVD-19 and for whom alternative COVID-19… (Source: News from Mayo Clinic)
Source: News from Mayo Clinic - December 23, 2021 Category: Databases & Libraries Source Type: news

FDA Authorizes Pfizer Antiviral Pill for COVID-19 FDA Authorizes Pfizer Antiviral Pill for COVID-19
Although the agency was expected to also authorize an antiviral from Merck, only Pfizer's was cleared for use Wednesday.FDA Approvals (Source: Medscape Internal Medicine Headlines)
Source: Medscape Internal Medicine Headlines - December 22, 2021 Category: Internal Medicine Tags: Infectious Diseases News Alert Source Type: news

FDA Authorizes Pfizer Antiviral Pill for COVID-19
The FDA was also expected to authorize an antiviral pill from Merck, but as of Wednesday afternoon, only Pfizer's had been authorized for use. (Source: WebMD Health)
Source: WebMD Health - December 22, 2021 Category: Consumer Health News Source Type: news

The FDA Just Authorized the First COVID-19 Pill, a Pfizer Drug That Can Be Taken At Home
U.S. health regulators on Wednesday authorized the first pill against COVID-19, a Pfizer drug that Americans will be able to take at home to head off the worst effects of the virus. The long-awaited milestone comes as U.S. cases, hospitalizations and deaths are all rising and health officials warn of a tsunami of new infections from the omicron variant that could overwhelm hospitals. The drug, Paxlovid, is a faster, cheaper way to treat early COVID-19 infections, though initial supplies will be extremely limited. All of the previously authorized drugs against the disease require an IV or an injection. [time-brightcove not-...
Source: TIME: Health - December 22, 2021 Category: Consumer Health News Authors: MATTHEW PERRONE / AP Tags: Uncategorized COVID-19 healthscienceclimate wire Source Type: news

Covid UK: Government buys 4m extra doses of Pfizer and Merck at-home antiviral pills to beat Omicron
Included in the order are 2.5million more doses of Pfizer's Paxlovid, which has been shown to slash the risk of vulnerable adults being hospitalised by up to 90%, and 1.75m courses of Lagevrio. (Source: the Mail online | Health)
Source: the Mail online | Health - December 22, 2021 Category: Consumer Health News Source Type: news

FDA to authorize the use of antiviral Covid pills developed by Pfizer and Merck later this week
Both molnupiravir and paxlovid are expected to receive authorization from the FDA at some point this week. The antiviral pills are believed to become important tools in the fight against Covid. (Source: the Mail online | Health)
Source: the Mail online | Health - December 21, 2021 Category: Consumer Health News Source Type: news

Telix secures FDA clearance for prostate cancer PET imaging agent
Telix Pharmaceuticals has secured clearance from the U.S. Food and Drug Administratio...Read more on AuntMinnie.comRelated Reading: Telix applauds NCCN radiotracer update Telix, Kettering to research PSMA radiotracer Lightpoint, Telix ink collaboration agreement Telix works with Merck on cancer therapies Telix Japan names COO (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - December 20, 2021 Category: Radiology Source Type: news

Merck Acquires Chord Therapeutics to Expand Neuroinflammatory Pipeline
Chord Therapeutics was launched by Omega Funds in October 2020 to develop new oral treatments for rare neuroinflammatory diseases Merck to accelerate development of Chord's innovative pipeline for generalized Myasthenia Gravis (gMG) and Neuromyelitis Op... Biopharmaceuticals, Neurology, Mergers & Acquisitions Chord Therapeutics, Merck (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 20, 2021 Category: Pharmaceuticals Source Type: news

Indian Pharmaceutical Manufacturers Are Ready To Bring Covid Antivirals To The World
Manufacturers in India are gearing up to produce generic versions of Pfizer and Merck ’s antivirals and can make millions of pills a month. They just need regulators to give them the okay. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - December 17, 2021 Category: Pharmaceuticals Authors: Aayushi Pratap, Forbes Staff Tags: Healthcare /healthcare Innovation /innovation Coronavirus Editors' Pick editors-pick Source Type: news

Britain Banking on COVID Antivirals to Get Through Omicron Winter Britain Banking on COVID Antivirals to Get Through Omicron Winter
Britain expects to have antiviral COVID-19 pills produced by Merck& Co Inc and Pfizer available over the winter, its Antiviral Taskforce Chair said on Thursday, as Omicron continues its lightning advance through the country.Reuters Health Information (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - December 17, 2021 Category: Intensive Care Tags: Infectious Diseases News Source Type: news

Pfizer confirms COVID pill's results, potency versus omicron
The Food and Drug Administration is expected to soon rule on whether to authorize Pfizer's pill and a competing pill from Merck, which was submitted to regulators several weeks earlier. If granted, the pills would be the first COVID-19 treatments that Americans could pickup at a pharmacy and take at home. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 15, 2021 Category: Pharmaceuticals Source Type: news

Pfizer Confirms COVID-19 Pill ’s Results, Potency Versus Omicron
WASHINGTON — Pfizer said today that its experimental pill to treat COVID-19 appears effective against the omicron variant. The company also said full results of its 2,250-person study confirmed the pill’s promising early results against the virus: The drug reduced combined hospitalizations and deaths by about 89% among high-risk adults when taken shortly after initial COVID-19 symptoms. Separate laboratory testing shows the drug retains its potency against the omicron variant, the company announced, as many experts had predicted. Pfizer tested the antiviral drug against a man-made version of a key protein that ...
Source: TIME: Health - December 14, 2021 Category: Consumer Health News Authors: MATTHEW PERRONE / AP Tags: Uncategorized COVID-19 healthscienceclimate Source Type: news

Merck ’s Covid Pill Might Pose Risks for Pregnant Women
Some laboratory studies suggest that molnupiravir can insert errors in DNA, which could in theory harm a developing fetus, sperm cells or children. (Source: NYT Health)
Source: NYT Health - December 13, 2021 Category: Consumer Health News Authors: Benjamin Mueller Tags: Molnupiravir (Drug) Drugs (Pharmaceuticals) Coronavirus (2019-nCoV) Research DNA (Deoxyribonucleic Acid) Birth Defects Pregnancy and Childbirth Merck & Company Inc your-feed-science Source Type: news

The Big Pivot: Merck Falters on Covid-19 Vaccine, Then Makes One for Rival J & J - WSJ
The partnership between the two competitors is now bearing fruit to expand the world’s vaccine supply. The first Merck-made Johnson & Johnson shots shipped Friday. #merck (Source: Reuters: Health)
Source: Reuters: Health - December 11, 2021 Category: Consumer Health News Source Type: news

Britain Starts Recruiting for Real-World COVID Antiviral Trial Britain Starts Recruiting for Real-World COVID Antiviral Trial
British researchers on Wednesday started recruitment for a clinical trial to test antiviral COVID-19 treatments for use in people early on in the disease who are at higher risks of complications, starting with Merck's molnupiravir.Reuters Health Information (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - December 10, 2021 Category: Intensive Care Tags: Infectious Diseases News Source Type: news

Lab Notes: Arbutus and Penn make headway on Covid-19 treatments; Carisma partners with Merck
Penn researchers are studying whether a chewing gum laced with a plant-grown protein can lower the transmission of Covid-19. (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - December 10, 2021 Category: American Health Authors: John George Source Type: news

New Covid Antiviral Pills Offer Hope as Omicron Looms
Merck and Pfizer will soon debut prescription pills to treat Covid-19. And more drugs are on the way. (Source: NYT Health)
Source: NYT Health - December 7, 2021 Category: Consumer Health News Authors: Carl Zimmer Tags: Molnupiravir (Drug) Coronavirus (2019-nCoV) Clinical Trials Drugs (Pharmaceuticals) Research your-feed-science Source Type: news

Thermo Fisher to manufacture Merck's Covid-19 pills in Canada
Thermo Fisher Scientific Inc. has struck a deal with Merck& Co. to manufacture its experimental Covid-19 pills in Canada, Reuters reported Monday. Waltham-based Thermo Fisher (NYSE: TMO) will make the pill, an antiviral called molnupiravir, at its site in Ontario. Pills made at the facility will be for distribution in Canada and the U.K., plus some other global markets. Merck (NYSE: MRK) has three manufacturing sites in total for molnupiravi r, but it also has a licensing agreement with the United… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - December 6, 2021 Category: Pharmaceuticals Authors: Rowan Walrath Source Type: news

Merck takes aim at Pfizer’s Covid pill as concerns linger over its own drug
Executive says patients on other medications will not be able to take rival antiviral treatment (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - December 5, 2021 Category: Pharmaceuticals Source Type: news

U.S. Drugstores Under Pressure From Demand for Vaccines Amid Staff Shortages
A rush of vaccine-seeking customers and staff shortages are squeezing drugstores around the U.S., leading to frazzled workers and temporary pharmacy closures. Drugstores are normally busy this time of year with flu shots and other vaccines, but now pharmacists are doling out a growing number of COVID-19 shots and giving coronavirus tests. The push for shots is expected to grow more intense as President Joe Biden urges vaccinated Americans to get booster shots to combat the emerging omicron variant. The White House said Thursday that more than two in three COVID-19 vaccinations are happening at local pharmacies. And pharmac...
Source: TIME: Health - December 4, 2021 Category: Consumer Health News Authors: Tom Murphy/AP Tags: Uncategorized COVID-19 wire Source Type: news

FDA approves pembrolizumab for adjuvant treatment of Stage IIB or IIC melanoma  
On December 3,2021, the Food and Drug Administration  approved pembrolizumab (Keytruda, Merck) for the adjuvant treatment of adult and pediatric (≥12 years of age) patients with stage IIB or IIC melanoma following complete resection. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - December 3, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA advisory committee recommends emergency authorization of Merck's Covid pill
An FDA advisory committee voted 13-10 in favor of recommending emergency use authorization of Merck & Co's pill to treat mild-to-moderate COVID-19 patients. (Source: the Mail online | Health)
Source: the Mail online | Health - December 1, 2021 Category: Consumer Health News Source Type: news

US panel backs first-of-a-kind COVID-19 pill from Merck
U.S. health advisers have endorsed an antiviral drug from Merck to treat COVID-19 (Source: ABC News: Health)
Source: ABC News: Health - December 1, 2021 Category: Consumer Health News Tags: Health Source Type: news

An F.D.A. panel endorses Merck ’s Covid pill for high-risk adults.
The drug, molnupiravir, could be authorized within days for patients at high risk of severe illness. (Source: NYT Health)
Source: NYT Health - December 1, 2021 Category: Consumer Health News Authors: Rebecca Robbins and Carl Zimmer Tags: Molnupiravir (Drug) Coronavirus (2019-nCoV) Merck & Company Inc Food and Drug Administration Coronavirus Omicron Variant Vaccination and Immunization Source Type: news

FDA Panel Narrowly Backs a First-of-a-Kind COVID-19 Antiviral Pill Made By Merck
WASHINGTON (AP) — A panel of U.S. health advisers on Tuesday narrowly backed a closely watched COVID-19 pill from Merck, setting the stage for a likely authorization of the first drug that Americans could take at home to treat the coronavirus. A Food and Drug Administration (FDA) panel voted 13-10 that the drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy. The recommendation came after hours of debate about the drug’s modest benefits and potential safety issues. Experts backing the treatment stressed that it should not be used by anyone who is pregnant and call...
Source: TIME: Health - November 30, 2021 Category: Consumer Health News Authors: MATTHEW PERRONE / AP Tags: Uncategorized COVID-19 wire Source Type: news