// Biotech and Pharma Therapeutics
J&J sees potential for 14 new multibillion-dollar drugs by 2025
November 18, 2021 / J&J / Drug Pricing / 2025
Johnson & Johnson (JNJ.N) expects to file for approval of 14 new drugs by 2025, and has projected average peak sales of $4 billion a year for each, a top J&J scientist said ahead of a strategy review of the company’s pharmaceuticals unit on Thursday.
Bayer CEO Rejects a Breakup After J&J and General Electric Split
November 17, 2021 / Bayer / J&J / General Electric
Bayer AG’s chief executive officer said the conglomerate will continue to run its three main business units under one roof, even as investor interest in the potential for splits among large diversified companies has intensified.
FDA approves Merck’s Keytruda as first immunotherapy for early kidney cancer
November 18, 2021 / FDA / Merck / Kidney Cancer / Immunotherapy
Approval of Keytruda in this setting comes about six months after Merck revealed early results from a study called Keynote-564, which showed the immunotherapy could help keep kidney cancers in remission for longer.
Bayer Bullish About CKD Drug Kerendia’s Prospects Following Trial Results
November 14, 2021 / Bayer / New Drug / Kerendia / Trial Results
Pharma giant Bayer is bullish about the prospects of its heart and kidney disease drug Kerendia after new data showed that the medication can work well with well-established SGLT2 diabetes meds.
Pfizer strikes deal to allow generic versions of its Covid pill for world’s poor
November 16, 2021 / Pfizer / Covid / FDA / WHO
US pharmaceutical giant Pfizer has announced a deal to make its prospective antiviral Covid-19 pill available more cheaply in the world’s least-wealthy countries. Pfizer will allow generic manufacturers to supply its promising Paxlovid pill to 95 low-and middle-income nations covering about 53% of the world’s population, the company said in a statement on Tuesday.
// 4th Industrial Revolution
Why Pharma Should Develop a Core Digital Offering
November 15, 2021 / Pharma / New Tech / Core Digital Offering
Digital health tools have become an important part of the health landscape, with more than 90,000 digital health apps released last year alone. The vast quantity of new digital solutions on the market, however, raises the question about how many of them are really effective.
Study: Digital tools don’t improve physical activity for people with low socioeconomic status
November 16, 2021 / Digital Tools / New Tech / New Study / Wearable Tech
Prescription VR pain relief earns FDA nod
November 18, 2021 / VR / Pain Relief / FDA
The FDA has OK’d a prescription-only virtual reality system that patients with chronic back pain can use at home to relieve their suffering.
Fish-Shaped Microrobots to Deliver Chemotherapy to Tumors
November 19, 2021 / Robotics / Chemotherapy / Tumors / Cancer
Researchers from the University of Science and Technology of China, working with outside collaborators, have developed shape-shifting microrobots that are designed to be guided to a target area in the body using magnets, and then release a drug cargo in response to the local environment.
The emerging golden era of neuroscience
November 18, 2021 / Neuroscience / J&J / Drug Development
Bill Martin is the Global Therapeutic Area Head of Neuroscience at The Janssen Pharmaceutical Companies of Johnson & Johnson. In an interview, he shared some of the promising developments in the neuroscience space, such as the rise of neuro-immunology, new ways to measure and monitor the potential for schizophrenia relapse, and the industry’s embrace of digital health tools to support drug development.
// Business & Markets
Denmark’s Novo Nordisk to buy Dicerna Pharma for $3.3 billion
November 18, 2021 / Denmark / Novo Nordisk / Dicerna Pharma
With the deal, Novo is following rivals including Novartis (NOVN.S) by betting on RNA interference technology, or RNAi, where genes that contribute to disease are silenced or rendered ineffective. Genes play a primary role in thousands of diseases.
Where will Novartis spend the $21B from Roche stake sale? Alnylam buyout could be one: report
November 18, 2021 / M&A / Mergers and Acquisitions / Rare Diseases / Alnylam
Novartis is getting a huge influx of cash from selling its 20-year stake in Roche, triggering speculation about where the Swiss pharma will spend the money. Another large acquisition could be next, with a familiar face now reportedly on the shopping list.
Ro takes $30M bet on weight loss production Plenity
November 18, 2021 / RO / Gelesis / Medical Device
Ro is taking bets on the weight loss industry with a $30 million prepaid order of diet pill Plenity. The New York-based company inked a deal with Plenity creator Gelesis in 2019 to offer the product as part of Ro’s virtual care services.
Novo to acquire Dicerna for more than $3B amid RNA drug resurgence
November 18, 2021 / Dicerna / Novo Nordisk / New Acquisition / RNA / Diabetes
Diabetes drug specialist Novo Nordisk has agreed to acquire Dicerna Pharmaceuticals in a deal worth $3.3 billion, a strategic bet that an existing wide-ranging alliance between the two will yield multiple medicines for a range of diseases.
CVS to close 900 stores, turn some into primary care sites
November 18, 2021 / CVS / Primary Care / HealthHUB
The pharmacy chain plans to organize its stores into three formats: traditional CVS Pharmacies, an enhanced version of its “HealthHUB” stores, and sites dedicated to primary care services. The company declined to elaborate further on its primary care plans, but in a recent Fortune interview, CEO Karen Lynch said the company plans to revamp hundreds of its stores into locations devoted to primary care.
// Legal & Regulatory
J&J Pharma Exec Reveals Playbook for Stand-Alone Drugmaker
November 18, 2021 / J&J / Drugmakers / Medical Devices
Johnson & Johnson will focus on developing drugs for conditions such as lung cancer and eye disease as it prepares to make its pharmaceutical and medical-devices business an independent entity.
Three Pharma Companies Seek to Address FDA Rejections
November 17, 2021 / FDA / FDA Rejections / Iterum Therapeutics
Iterum Therapeutics will head back into the clinic to meet regulatory requirements to refile a New Drug Application (NDA) for oral sulopenem, which has been developed to treat uncomplicated urinary tract infections (uUTI).
Bayer, Dr. Reddy’s end patent dispute over generic of cancer drug Nexavar
November 18, 2021 / Bayer / Cancer / New Drug / Nexavar
Bayer Healthcare and Amgen subsidiary Onyx Pharmaceuticals have agreed to drop their patent lawsuit against Dr. Reddy’s Laboratories over its proposed generic version of their cancer drug Nexavar.
Pfizer asks FDA to authorize COVID-19 pill
November 16, 2021 / COVID-19 / FDA / Pfizer /
Pfizer’s pill is the second oral drug for COVID-19 to be proven strongly effective in large, placebo-controlled clinical trials after Merck’s molnupiravir, which early in November was authorized by regulators in the U.K.
FDA asks for 55 years to complete FOIA request on Pfizer’s COVID-19 vaccine
November 19, 2021 / Coronavirus / COVID-19 / Comirnaty / Pfizer
Hungry for details on Pfizer’s COVID-19 vaccine? Just file a Freedom of Information Act (FOIA) request and wait until the U.S. tricentennial in 2076. That’s the schedule the FDA proposed in documents filed in a U.S. District Court this week.
// Research & Development
A Lesson Learned From Big Pharma: Don’t Be Afraid To Go Global
November 9, 2021 / Big Pharma / KZR-616 / Kezar
Kezar Life Sciences was founded in 2015 to fight immune-mediated and oncologic disorders. Christopher Kirk, company president, co-founder, and CSO, notes Kezar is pioneering small-molecule therapies that harness master regulators of cellular function to inhibit multiple drivers of disease via single, powerful targets. The company’s research in protein degradation and protein secretion will be used to impact difficult-to-treat diseases.
Study shows immune cells against COVID-19 stay high in number six months after vaccination
November 16, 2021 / COVID-19 / Vaccine / New Study
A recent study by Johns Hopkins Medicine researchers provides evidence that CD4+ T lymphocytes — immune system cells also known as helper T cells — produced by people who received either of the two available messenger RNA (mRNA) vaccines for COVID-19 persist six months after vaccination at only slightly reduced levels from two weeks after vaccination and are at significantly higher levels than for those who are unvaccinated.
New gene Identified that contributes to progression to type 1 diabetes – California News Times
November, 2021 / New Gene / Diabetes / California / CCR2
Dr. Sharad Purohit and Paul Tran, an MD / PhD student report that the combination of a pro-inflammatory pair of receptors called CCR2 and its ligand, CCL-2, increases the risk of developing type 1 diabetes.
Researchers discover new insights about tau proteins in people living with ALS
November 15, 2021 / New Insights / tau Proteins / ALS
A team led by investigators at Massachusetts General Hospital (MGH) has shown that people living with amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, who carry a mutation in the C9orf72 gene exhibit elevated levels of tau and phosphorylated tau protein in the motor cortex region of the brain. The research, which is published in Brain Pathology, also identified new genetic mutations in the tau gene and revealed that the ratio of different forms of tau protein may be an indicator of disease progression in ALS.
Better Therapeutics completes enrollment in type 2 diabetes study
November 19, 2021 / Better Therapeutics / Diabetes / Type 2 / New Study
According to a news release, the trial for BT-001 exceeded its enrollment target, bringing in 662 patients from centers across California, Illinois, Florida, Georgia, New York and Texas. Positive study results may support regulatory submission to the FDA, Better Therapeutics said.
Biden’s Medicare drug price negotiation will leave pharma mostly unscathed: CBO
November 19, 2021 / Drug Costs / Drug Prices / Biden / Medicare
The pharma industry should emerge mostly unscathed if President Joseph Biden’s Build Back Better bill makes its way into law. While the legislation would open the door to limited Medicare negotiations and cap price hikes at the rate of inflation, the cost to the industry and its pace of innovation would be minimal, a government analysis found.
Inflation Fears, Pharma Interests Could Alter Drug Pricing Measures
November 17, 2021 / Inflation / Drug Pricing / U.S. Senate
Read about the biggest pharmaceutical developments and pricing stories from the past week in KHN’s Prescription Drug Watch roundup.
The Build Back Better bill wants to lower prescription drug costs. Does it go far enough?
November 17, 2021 / Drug Prices / Biden / Build Back Better
Even while President Joe Biden is promoting the new infrastructure package, he and Democrats are trying to lock down a vote on a social spending and climate bill — The Build Back Better Act. Part of that bill is aimed at lowering prescription drug prices for older Americans. Amna Nawaz takes a look at what’s at stake in this bill.
Health Care Renovation
November 18, 2021 / Healthcare / Biden / Social Policy Bill
We’re looking at the ways Biden’s social policy bill will change health care.
Biden’s Overdose Prevention Plan Faces Social, State Barriers
November 18, 2021 / Biden / Overdose Prevention / Drug Deaths
The Biden administration’s sweeping plan to quell rising drug deaths in the U.S. could face roadblocks as treatment specialists grapple with limitations in tracking overdoses and varying state regulations.