Pharma Update 8-23-21
According to Statusta, by year end 2020, the total global pharmaceutical market was valued at about $1.27 trillion. A significant increase from 2001 when it was valued at $390 billion. The pharmaceutical market plays a key role in how people get medications and what people pay for medication. At the intersection of healthcare, pharma, and technology, here are current news and announcements.
Trending News
Today, FDA approved the first COVID-19 vaccine for the prevention of #COVID19 disease in individuals 16 years of age and older. https://t.co/iOqsxXV1fj
— U.S. FDA (@US_FDA) August 23, 2021
Financial News
AstraZeneca sees first half improvement in sales and profits
Drugs giant AstraZeneca delivered strong revenue growth of 23% in its first half to $15.540bn, it revealed. In the second quarter revenue increased by 31% to $8.220bn.
EQRx Goes Public in $1.8 Billion Deal, Plans to Lower Drug Costs
Pharmaceutical startup company and NEC member EQRx has gone public by raising $1.8 billion through a merger with a special purpose acquisition company (SPAC). The deal will advance EQRx’s “New Pharma” platform which aims to drastically lower drug prices.
Prime Medicine Launches with $315 Million Financing to Deliver on the Promise of Prime Editing
Prime Medicine™, a company delivering on the promise of Prime Editing to provide lifelong cures to patients, announced its launch with $315 million in financing.
COVID Updates
Regeneron’s COVID-19 antibody cocktail can now be offered as a preventive measure, the FDA says
PhillyVoice reports that the U.S. Food and Drug Administration has expanded the use of Regeneron’s monoclonal antibody COVID-19 treatment to include prevention after exposure to the virus.
NRx Pharma Says No Safety Concerns Found for Covid-19 Treatment Zyesami
NRx Pharmaceuticals Inc. gave a safety update on Zyesami, saying a study’s data safety monitoring board found no new safety concerns in a trial and recommended continued enrollment.
Coronavirus (COVID-19) Update
The FDA announced the following actions taken in its ongoing response effort to the COVID-19 pandemic.
Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals
FDA amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
COVID Booster Shots Are Coming. Here’s What You Need To Know
Health officials are preparing to roll out COVID-19 booster shots in the United States this September. According to a plan announced, all U.S. adults who received a two-dose vaccine would be eligible for an additional jab of the Pfizer or Moderna vaccine eight months from when they got their second one.
Gritstone Bio In Funding Deal With CEPI To Advance Covid-19 Vaccine Program
Gritstone bio, Inc. (@gritstonebio) said it has entered into a funding deal of up to $20.6 million with the Coalition for Epidemic Preparedness Innovations (CEPI) to advance Gritstone’s second-generation Covid-19 vaccine program against SARS-CoV-2 Variants.
AstraZeneca’s antibody therapy prevents Covid, study shows
AstraZeneca’s new antibody therapy reduced the risk of people developing Covid-19 symptoms by 77% in a late-stage trial, putting the drugmaker on track to offer protection to those who respond poorly to vaccines.
FDA Approvals in the News
FDA approval of belzutifan culminates 25-year journey at UTSW from gene discovery to a first-in-class drug
A first-in-kind kidney cancer drug developed from laboratory and translational studies conducted at UT Southwestern Medical Center received approval from the Food and Drug Administration, providing a new treatment for patients with familial kidney cancer.
Abbott’s Amplatzer™ Amulet™ Device Approved by FDA to Treat People With Atrial Fibrillation at Risk of Stroke
Abbott (@AbbottNews) announced that the FDA approved the company’s Amplatzer™ Amulet™ Left Atrial Appendage Occluder to treat people with atrial fibrillation (AFib) who are at risk of ischemic stroke. The device offers immediate closure of the left atrial appendage (LAA) – an area where blood clots can form in people suffering from AFib – reducing their risk of stroke and immediately eliminating the need for blood-thinning medication.
FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes
The FDA approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus.
FDA Grants First of its Kind Indication for Chronic Sleep Disorder Treatment
FDA approved a new indication for Xywav for idiopathic hypersomnia (IH) in adults. IH is an uncommon chronic sleep disorder that causes people to be excessively sleepy during the day even after a good night’s sleep. Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution is already approved for the treatment of cataplexy or excessive daytime sleepiness in patients seven years or older with narcolepsy.
News & Noted
Marlboro owner wants to buy a company that makes asthma inhalers. Health charities say it must be stopped
A UK company that makes products to treat lung conditions could wind up in the hands of one of the world’s biggest cigarette makers, prompting an outcry from health charities that are calling on the British government to block the deal. Marlboro maker Philip Morris International (PMI) increased its offer for pharmaceutical company Vectura to more than £1 billion ($1.4 billion) in an attempt to fend off a rival bid from US private equity group Carlyle.
Lilly Announces Leadership Changes and Formation of Neuroscience and Immunology Business Units
Eli Lilly and Company (@LillyPad) announced executive leadership changes and the creation of neuroscience and immunology business units. These changes will increase Lilly’s focus on introducing breakthrough new medicines to millions of people with unmet needs.
Resources
The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
Upcoming Events
Cambridge Healthtech Institute (@CHI_Healthtech)
What: 13th Annual Next Generation Dx Summit
When: August 24 – 26, 2021
Where: In Person & Virtual, Grand Hyatt Washington, D.C. & Online (EDT)
Hashtag: #NGDx21
Register here.
Next Generation Dx Summit – Since 2009, the diagnostics community has united at Next Generation Dx Summit to discuss trend-setting developments, milestones, challenges and opportunities in the industry. Next Generation Dx Summit provides a venue to advance the science of diagnostics and improve the practice of medicine.
