// Biotech and Pharma Therapeutics
Lilly ‘won’t be discouraged’ if others fail in Alzheimer’s, neuroscience chief says
August 4, 2022 / Eli Lilly / Donanemab / Alzheimer’s
The senior vice president took the firm stance as Lilly announced that donanemab has been accepted for a priority review by the FDA in early onset Alzheimer’s under the accelerated review pathway, just like Biogen and Eisai’s offering that was accepted last month. The Indianapolis pharmaceutical company announced the news in its second quarter earnings report Thursday.
Look out, Pfizer. With new approval, Bayer’s Nubeqa is set to challenge Xtandi’s prostate cancer crown
August 8, 2022 / Bayer / Nubeqa / Prostate Cancer / FDA
The FDA has blessed Nubeqa with an approval to treat adults with metastatic hormone-sensitive prostate cancer (mHSPC). The green light clears the way for Nubeqa in later-stage disease, as well as non-metastatic castration-resistant prostate cancer (nmCRPC)—the indication where the med bagged its original approval back in 2019.
Bayer’s Xarelto squeeze rolls on as cancer newcomer Nubeqa gains steam
August 5, 2022 / Bayer / Xarelto / Nubeqa / Eylea
After a tough showing earlier this year, Bayer has logged another Xarelto downturn in the second quarter. The aging blood thinner continues to feel the squeeze from an aggressive drug discounting program in China.
J&J’s Mathai Mammen Abruptly Departs in Latest Leadership Jolt
August 9, 2022 / J&J / Mathai Mammen
In a brief announcement Monday night, life sciences giant Johnson & Johnson made the announcement about Mammen’s departure. There was no reference to another position that Mammen has agreed to take made by J&J. As of this morning, there are no announcements that Mammen has taken on a new role. In its report, J&J said it appreciates Mammen’s contributions over the past five years at the company.
Metabolon Announces Joint Development Agreement with Mayo Clinic to Create New Diagnostic Tests
August 9, 2022 / Metabolan / Mayo Clinic / Development Agreement
Metabolon, Inc., the global leader in metabolomics solutions advancing a wide variety of research, diagnostic, therapeutic development, and precision medicine applications, today announced a joint development agreement with Mayo Clinic to develop novel metabolomic biomarker diagnostic tests. Metabolon will analyze Mayo Clinic patient clinical samples across multiple cohorts to look for disease biomarkers. New diagnostic tests for Mayo Clinic to use in its nationwide Mayo Clinic Laboratories will be designed using these biomarkers.
// 4th Industrial Revolution
Puredyne refines bioprinting process
August 5, 2022 / Puredyne / Bioprinting
When 3D bioprinting with organic substances, it is hard to overstate the importance of not damaging the cells. Print heads from Puredyne, a brand of the established dispensing specialist ViscoTec, already prioritize this through demonstrably high-precision and low-shear dispensing, although the printing results are always dependent on the dispensing needle used, of which there are many available on the market, including the ones from Japanese manufacturer, Tecdia.
New model can predict best drug combinations for osteoporosis
August 9, 2022 / osteoporosis / New Model
The sudden loss of the hormone estrogen during menopause can interfere with the body’s natural processes for repairing natural wear and tear on bones, leading to more weakened bones and possible fractures. Several drugs are available to treat this type of postmenopausal bone loss. While these treatments can be combined, there is little evidence to suggest what the most effective combinations might be.
Lab-On-Chip System Simultaneously Detects SARS-CoV-2 RNA and Antibodies in Saliva
August 9, 2022 / Virology / Genome Editing / 3D Printing
A new, 3D-printed, lab-on-chip system combines eRapid and SHERLOCK technologies into a single, postcard-sized system that can simultaneously detect the presence of both SARS-CoV-2 RNA and antibodies against the virus in a patient’s saliva. The detection, which takes under two hours, occurs via multiplexed electrochemical outputs.
3-D Twinkle Protein Structure May Lead to Mitochondrial Disease Therapies
August 9, 2022 / DNA / Drug Discovery / Liver Diseases
Scientists at the NIH say they have developed a three-dimensional (3D) structure that allows them to see how and where disease mutations on the twinkle protein, which is involved in helping cells use energy our bodies convert from food, can lead to treatments for mitochondrial diseases.
Apriori Bio’s AI Platform Provides Variant-Proof Protection from Viral Threats
August 8, 2022 / AI / Drug Discovery / Vaccine Development
Flagship Pioneering announced the launch of Apriori Bio, a health security company providing variant-proof protection against rapidly evolving viruses. Apriori has developed Octavia, a unique biology-informed AI platform that can infer the full landscape of potential variants for a given virus. Using Octavia, Apriori can define the antibody repertoire that most broadly protects against current and future virus variants, enabling the development of variant-proof vaccines and antibody drugs.
// Business & Markets
In warranty program, Pfizer will refund up to $50K for patients who discontinue use of rare disease drug
August 9, 2022 / Pfizer / Xalkori / Value-based contracting / Takeda
Over the last several years however, some drugmakers have begun to experiment with money-back guarantees for their products. Count Pfizer among them. Last year the pharma giant introduced its first warranty program, using it to promote lung cancer drug Xalkori. Now Pfizer has opened a similar program for newly approved Panzyga, which treats the rare disorder chronic inflammatory demyelinating polyneuropathy (CIPD).
Verona’s shares jump as COPD drug hits goal in phase 3, teeing up FDA filing
August 9, 2022 / Verona / Clinical Trial Data / Nebulizer
Verona Pharma has hit the mark in its first of two phase 3 chronic obstructive pulmonary disease (COPD) clinical trials, keeping it on course to file for FDA approval of the inhaled PDE3 and PDE4 inhibitor in the first half of next year. Shares in Verona rose around 30% to the region of $9 in premarket trading.
Merck Returns to Alzheimer’s Disease with $1.1B Cerevance Pact
August 9, 2022 / Merck / Alzheimer’s / Cerevance
With an investment valued at up to $1.1 billion, Merck is diving back into Alzheimer’s research through a collaboration with Cerevance. Using Cerevance’s proprietary Nuclear Enriched Transcript Sort sequencing (NETSseq) technology platform, the two companies have partnered to identify new targets for the treatment of Alzheimer’s disease (AD).
Aytu BioPharma Announces Pricing of Public Offering
August 9, 2022 / BioPharma / Public Offering
The Company intends to use the net proceeds from the Offering for advancing the development of its pipeline assets, including for advancing the PREVEnt Trial evaluating AR101 for the treatment of vascular Ehlers-Danlos Syndrome (VEDS), for growth of the company’s commercial business, and for working capital and general corporate purposes.
Bodyport Receives FDA Clearance for the Bodyport Cardiac Scale
August 9, 2022 / Bodyport / FDA Clearance / Cardiac Scale
More than 6 million adults in the United States have heart failure, costing the U.S. an estimated $30.7 billion annually and causing 12 million clinic visits and 1.2 million hospitalizations each year.i More than 90% of these hospitalizations are due to hemodynamic changes resulting in fluid accumulation.ii Weight monitoring is currently the noninvasive standard of care for detecting fluid changes in patients with heart failure.
// Legal & Regulatory
Bayer, Janssen Pharmaceuticals Sue Mylan for Patent Infringement of Xarelto
August 9, 2022 / Bayer / Janssen Pharma / Maylan / Patent Infringement
According to the complaint, Janssen is the holder of the new drug application for Xarelto which has been approved by the FDA. The complaint states that XARELTO is a factor Xa inhibitor and when it is administered orally it reduces the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease.
FDA turns away Acadia’s Nuplazid—again—this time in Alzheimer’s disease psychosis
August 5, 2022 / Acadia Pharma / Nuplazid / Complete Response Letter / FDA
The FDA determined that it could not approve Acadia’s drug to treat hallucinations and delusions associated with Alzheimer’s disease psychosis. Instead, the agency recommended Acadia run another trial.
Eli Lilly takes $61M hit in Medicaid whistleblower lawsuit, but remains adamant it will ‘ultimately prevail’
August 5, 2022 / Eli Lilly / Bristol Myers Squibb / Astellas Pharma / Medicaid
More than eight years after a former pharmacist sued Eli Lilly, Bristol Myers Squibb and other drugmakers for allegedly skimping out on Medicaid rebates, Lilly’s day in court has finally come. Now, a jury has found the Indianapolis-based company liable for defrauding the nation’s Medicaid program and ordered it to shell out $61 million in damages.
Haggling With Pharma: Medicare Drug Price Negotiations Explained
August 11, 2022 / Medicare Drug Price / Negotiations
The Congressional Budget Office has estimated that the provisions would save the Centers for Medicare & Medicaid Services roughly $102 billion over a decade. Some drug pricing analysts, however, question whether the bill (H.R. 5376) will actually reduce costs.
Merck defends tax approach against senator’s claims of avoidance
August 7, 2022 / Merck / U.S. Senate
Chief financial officer Caroline Litchfield said the company operates with the highest “ethics and integrity in absolutely everything we do” and is continuing to co-operate with the Senate finance committee’s investigation into its tax affairs.
// Research & Development
Protein that detects light may play a role in the origin and progression of melanoma, study suggests
August 9, 2022 / Melanoma / Study
In experiments with animals and genetically modified cells at the Comparative Physiology of Pigmentation Laboratory belonging to the Institute of Biosciences (IB-USP), the researchers showed that the disease advances more slowly when this protein is not functional. The findings are reported in an article published in Communications Biology.
AstraZeneca-Daiichi Sankyo’s ADC barrels forward as Keytruda combo data make case for lung cancer use
August 9, 2022 / BeiGene / Novartis / PD-1/L1 / Liver Cancer
AAs Novartis and BeiGene wait for a delayed FDA decision on what could be tislelizumab’s first U.S. approval, the PD-1 inhibitor has chalked up another clinical win. But how much that trial success matters in a potential fight against Roche’s first-to-market Tecentriq remains an open question. The latest trial win showed that tislelizumab matched up to Bayer’s aging Nexavar at extending the lives of patients with newly diagnosed unresectable liver cancer, BeiGene said Tuesday.
Postoperative Treatment May Improve Glioblastoma Survival Rates
August 9, 2022 / Glioblastoma / Postoperative Treatment
As SARS-CoV-2 has evolved and mutated, therapeutic antibodies that worked early in the pandemic have become less effective, and newer variants, especially Omicron, have developed ways to evade the antibodies we make in response to vaccines. A new, broadly neutralizing antibody developed at Boston Children’s Hospital could potentially improve our ability to defend against future variants.
Phage Therapy Starts Realizing Its Long-Deferred Potential
August 9, 2022 / Phage Therapy / Bacteria-killing viruses
Soon after bacteria-killing viruses were independently discovered by English physician Frederick Twort in 1915 and by French microbiologist Felix d’Herelle in 1917, the tiny microbes were seen to have therapeutic potential. Twort suggested that bacteria-depleted zones on his culture plates could have been caused by an “ultra-microscopic virus,” but he cautiously allowed that they might have been due to a strictly bacterial process of some kind. d’Herelle was bolder.
New Hydrogel to Extend the Shelf Life of Biologics
August 8, 2022 / Hydrogel / Biologics
Scientists have designed a new type of hydrogel that enables biologics such as antibodies, enzymes, and protein-based vaccines to withstand a greater range of temperature fluctuations without losing their functionality. This hydrogel may offer a new way to store and transport biologics, reducing costs and health risks associated with the cold chain.
Senate passage of drug pricing bill brings major defeat closer for pharma industry
August 8, 2022 / U.S. Senate / Drug Pricing
The $739 billion climate, tax and healthcare legislation, dubbed the Inflation Reduction Act, passed 51-50 on a party-line vote, with Vice President Kamala Harris casting the tie-breaker. The House of Representative will take up the measure on Friday and is expected to quickly pass it and send it to President Joe Biden for his signature. A pared-down version of the White House’s “Build Back Better” plan, the bill would still represent an important legislative victory for his administration.
Climate, health and tax debate moves quickly to campaign realm
August 9, 2022 / U.S. Senate / U.S. House Bill
The debate over the sweeping climate, health and tax bill passed by Senate Democrats last weekend is already moving to the campaign trail, even before the House has cleared it for President Joe Biden’s signature. One Nation, the nonprofit associated with the Senate Leadership Fund — the super PAC run by allies of Senate Minority Leader Mitch McConnell, R-Ky. — on Tuesday announced an ad blitz against the package, passed Sunday.
The fight is on: As US pricing reform advances through Congress, pharma gears up for a brawl
August 11, 2022 / Drug Prices / Medicare / PhRMA / Senate
Alongside climate and tax measures, Sunday’s Congressional package includes provisions that give Medicare the power to slash drug prices and cap out-of-pocket spending for seniors. The bill, which still needs to go through the House to become law, also requires drugmakers to pay a Medicare rebate if their prices rise faster than the rate of inflation.
Franken lauds Inflation Reduction Act, criticizes Grassley
August 9, 2022 / Franken / Inflation Reduction Act
Franken said the bill would lower prescription drug costs for families by placing limits on how much families and Medicare can be charged for vital medicines. Among other provisions, the measure gives Medicare the ability to negotiate the price of certain prescription drugs and caps annual out-of-pocket prescription drug costs at $2,000 for Medicare enrollees starting in 2025.
Democrats’ Long-Sought Plan for Lowering Drug Costs Is at Hand
August 5, 2022 / Drug Costs
Now they are on the verge of passing a broad budget bill that would do just that, and in the process deliver President Biden a political victory that he and his party can take to voters in November.