WHO Draft Pandemic Rules Could Make Pharma Disclose Prices
New draft rules by the World Health Organization (WHO) may force pharma companies to reveal the prices of any drugs under public procurement contracts. This comes after criticism of the industry over a lack of pricing transparency regarding therapeutics like vaccines during the COVID-19 pandemic.
Study Finds Most US Adults Don’t Know About Upcoming Medicare Eligibility Redeterminations
A newly published report from the Robert Wood Johnson Foundation finds that most US adults with a family member on Medicaid are unaware of impending eligibility redeterminations. The redeterminations are set to hit after the COVID-19 public health emergency is ended by the federal government. Many current Medicaid recipients are at risk of losing coverage.
Real-World Evidence Studies Show Efficacy of COVID-19 Therapeutics
Two new real-world evidence studies exploring the efficacy of two treatments for COVID-19 have been published in the British Medical Journal (BMJ). The first study investigated real-world data (RWD) from fully vaccinated high-risk adult patients in England. Those taking sotrovimab had better COVID-19 outcomes than people taking molnupiravir, most notably a 46% reduction in severe COVID-19.
NICE Makes New Round of COVID-19 Drug Approval Recommendations
The UK’s NICE has announced its recommendations of approval for three COVID-19 drugs and the rejection of five others based on value and efficacy data. Paxlovid, RoActemra, and Olumiant from Pfizer, Roche, and Eli Lilly, respectively, made the cut. Uncertain efficacy data and pricing issues sank the applications of drugs from Merck, Gillead, GSK, Regeneron, and AstraZeneca
Pfizer Considering 400% COVID-19 Vaccine Price Increase in US
Since their release to the general public last year, the US government has been purchasing and providing COVID-19 vaccines free of charge to patients. With this program set to end soon as public demand for the vaccine draws down, Pfizer is looking to hike its price up by 400% as it enters the commercial market.
Real-World Data Study Gives Look at Merck’s COVID Drug’s Performance After Middling Sales
Merck’s COVID-19 drug Lagrevio has suffered from middling sales since its emergency use authorization last December, with 755,000 of 2.5 million doses used. New real-world data (RWD) from the PANORAMIC study has shown positive results, with patients reporting that it cut average recovery times by 6 days. In addition, it cut the number of patients with detectable viral loads at day seven from 34 to 29.
Eiger’s Scraps Emergency Use Authorization Submission for COVID-19 Treatment
The US Food and Drug Administration has rejected Eiger BioPharmaceuticals’ request to meet with the agency regarding peginterferon lambda, its repurposed hepatitis D treatment for use in COVID-19. The company asked for the meeting to discuss an emergency use authorization in September based on data from the TOGETHER Phase III trial. However, it appears the data was insufficient for the agency.
Biden Declares Pandemic is Over – Vaccine Stocks Take a Hit
US President Joe Biden declared the pandemic ‘over’ in a “60 Minutes” interview this Sunday, September 18th. In response, many vaccine manufacturers saw a drop in share prices, including Moderna, Novavax, and BioNTech. This reflects a larger dip in the biotech market, particularly companies working with COVID-19 therapeutics.
South African Biotech Biovac Produces First Batch of COVID-19 Vaccine
Biovac, a vaccine producer located in South Africa, has produced its first batch of Pfizer and BioNTech’s mRNA vaccine. The company was added to Pfizer and BioNTech’s vaccine manufacturing network just over a year ago. The South African Health Regulatory Products Authority still needs to inspect the vaccines before they can be distributed.
EU’s CHMP Recommends Evusheld by Astrazeneca for Use in Treating COVID-19
Astrazeneca has received a conditional recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its COVID-19 treatment Evusheld. The treatment contains two antibodies against the SARS-CoV-2 virus produced by donated B-cells from people who’ve had COVID-19 in the past.
WHO Conditionally Recommends Remdesivir for Severe COVID-19
The World Health Organization (WHO) has conditionally recommended Gilead’s COVID-19 antiviral Remsdesivir (Veklury), which was already conditionally recommended for non-severe COVID-19. The recommendation was made on positive results from the organization’s SOLIDARITY, which found that patients had a 13% decrease to relative risk of mortality in severe COVID-19 patients.
EU Commission Approves Novavax COVID-19 Boosters
The EU Commission has approved the Novavax COVID-19 vaccine booster for adults 18 and above. The move comes only weeks after the European Medicine Agency (EMA) recommended the use of booster doses of the protein-based vaccine. The shot is currently authorized for the purpose in 3 APAC countries, Japan, New Zealand, and Japan.
Moderna Looking At $100 COVID-19 Vaccines
With the US federal government ending free COVID-19 vaccines by the end of 2022, Moderna has begun deliberating the cost it will charge for the shots on the commercial market. Arpa Garay, COO of Moderna, spoke with investors Tuesday, September 8th, informing them of the company’s move towards value-based pricing. The proposed $100 price tag would be triple that paid by the US government during the ongoing pandemic.
India Approves Nasal COVID-19 Vaccine by Bharat Biotech
The Drugs Controller General of India (DCGI) has approved Bharat Biotech’s nasal COVID-19 vaccine for adults 18 and over. This is the first of its kind in the nation and is one of few nasal COVID-19 vaccines approved worldwide. Based on a modified chimpanzee cold virus, the vaccine delivers SARS-CoV-2 spike proteins directly to the nose, one of the first spots in the virus’s route of infection.
Doctors Looking for Answers on Long COVID on Their Own
Healthcare practitioners are having to take long COVID treatment into their own hands, with dedicated clinics popping up to meet this growing need. Unfortunately, the federal government has yet to devote the resources to tackling the issue, releasing no official guidances for treating the chronic condition. Some clinicians are collaborating on treatment methods, but more support is needed for patients and their providers.
UK Begins Pfizer/BioNTech’s Bivalent Omicron COVID-19 Vaccine Booster Shot Program
The UK’s NHS has begun the rollout of Pfizer/BioNTech’s bivalent COVID-19 boosters. The launch comes after the Medicines and Healthcare Products Regulatory Agency (MHRA) approved the shot for those 12 and older last week. The vaccine contains spike protein mRNA from both the original SARS-CoV-2 virus and the BA.1 Omicron strain.
COVID-19 Antibody Treatments Continue Well After FDA Deauthorization
Despite the best efforts of the US Food and Drug Administration (FDA), the use of Eli Lilly and Regeneron’s monoclonal COVID-19 antibody treatments is still prevalent. Nearly 160,000 doses of the therapeutics have been given since the two were deauthorized by the FDA this January. An estimate of the total healthcare cost is approximately $71 million.
Pfizer and BioNTech’s Bivalent COVID-19 Vaccine Boosters Get EU Approval
The European Medicines Agency (EMA) has just issued conditional marketing authorization (CMA) for both Pfizer and BioNTech’s bivalent COVID-19 vaccines. The agency’s Committee for Medicinal Products for Human Use (CHMP) approved the vaccines as boosters for people 12 and up. These vaccines contain spike protein mRNA for the original SARS-CoV-2 virus and the BA.4/BA.5 Omicron strains currently dominant across the globe.
UK MHRA Approves Novavax COVID-19 for Ages 12-17
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has given expanded conditional marketing authorization (CMA) to use the Novavax COVID-19 vaccine in people ages 12-17. The decision was made based on data from the PREVENT-19 phase 3 trial. Early data showed that it had an 80% clinical efficacy during the US’s delta wave.
FDA Approves Bivalent COVID-19 Vaccines from Moderna and Pfizer/BioNTech
The US Food and Drug Administration (FDA) has approved both bivalent COVID-19 vaccine boosters from Moderna and Pfizer/BioNTech. The boosters contain spike pro mRNA from the original SARS-CoV-2 virus and the BA.4/BA.5 omicron strains currently dominant worldwide. The approval comes as the agency waits for more human data to come in.
AstraZeneca Launches New Real-World Evidence Study for Evushield COVID-19 Therapeutic in Abu Dhabi
AstraZeneca has announced the launch of a real-world evidence (RWE) study to investigate the safety and efficacy of Evushield, its COVID-19 treatment. Evushield is an antibody combination with an extended duration that is intended to help immunocompromised patients avoid symptomatic COVID-19. The project, entitled the “EVOLVE Real World Evidence Study,” will include 1,000 participants and will run through 2023.
Authorization for Bivalent Omicron Boosters
Insider sources say that the US Food and Drug Administration could authorize the new bivalent COVID-19 vaccines from Moderna and Pfizer/BioNTech as early as Labor Day, September 5th. The vaccines contain mRNA for spike protein from the BA.4/BA.5 SARS-CoV-2 that currently dominating worldwide and the spike protein from the original strain from 2019 and early 2020.
FDA Commissioner Rob Califf Emphasizes Need to Combat Misinformation
Rob Califf, the commissioner of the US Food and Drug Administration (FDA), spoke about his current goals for the agency. Califf emphasized the need to continue focusing on the ongoing COVID-19 pandemic and the opioid epidemic. The nation is behind its peers in terms of vaccinations, and Americans are growing increasingly tired of COVID-19 restrictions.
Pfizer, BioNTech Apply for FDA Emergency Use Authorization for Omicron Booster
The makers of the Comirnaty COVID-19 vaccine have applied to the US Food and Drug Administration (FDA) for an emergency use authorization for their new Omicron BA.4 and BA.5 booster shots. The new version of Pfizer and BioNTech’s vaccine is bivalent, containing spike protein mRNA from the original SARS-CoV-2 and Omicron BA.4/BA.5.
Anthony Fauci to Step Down in December
On Monday, August 23rd, Anthony Fauci announced his plans to step down from his roles in the National Institute of Health (NIH) and the Biden Administration. Fauci had served as the director of the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) for 38 years, and had spent over 50 working for the US government in total. However, this move is not the end of his career, he maintains.
