// 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. Read Full Article on Fierce Pharma >>
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. Read Full Article on Fierce Pharma >>
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. Read Full Article on Fierce Pharma >>
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. Read Full Article on Biospace >>
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. Read Full Article on Biospace >>
Pfizer’s $5.4B GBT buy adds potential sickle cell disease ‘cure’ and former Sanofi candidates
August 8, 2022 / Pfizer / Global Blood Therapeutics / M&A / Sickle Cell Disease Writing on Saturday—before the deal was announced—SVB Securities analysts suggested that an offer of around $5 billion “would encompass enough premium to capture the pipeline value and growth of [GBT], including un-risk adjusted value for the key pipeline asset GBT601, a potential ‘functional cure’ for sickle cell disease.” Read Full Article on Fierce Biotech >>
After delay, Myovant and Pfizer’s Myfembree nabs FDA nod for endometriosis
August 8, 2022 / Pfizer / Myfembree / Myovant / Endometriosis After a bump in the road back in April, Myovant and Pfizer have won a label expansion covering Myfembree’s use in endometriosis. Read Full Article on Fierce Pharma >>
Johnson & Johnson And Hospital Giant HCA To Tackle Health Equity
August 9, 2022 / J&J / HCA / Healthcare The partnership between a major hospital operator and maker of medical products comes as the industry looks to address health equity through a variety of forms and models. Initially, the partnership’s efforts will work on various programs to educate nurses by incorporating Johnson & Johnson’s nursing resources within HCA Healthcare and its affiliate Galen College of Nursing. Read Full Article on Forbes >>
Amgen to Acquire ChemoCentryx for $3.7B, Bolstering Autoimmune Portfolio
August 5, 2022 / Amgen / Drug Discovery / Autoimmune Disease Amgen has agreed to acquire ChemoCentryx for approximately $3.7 billion, the companies said today, in a deal that expands the buyer’s autoimmune portfolio with an approved drug and two clinical phase candidates. Read Full Article on GEN Edge >>

// 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. Read Full Article on 3D Printing Media >>
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. Full Article on Medical Press >>
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. Read Full Article on GEN Edge >>
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. Read Full Article on GEN Edge >>
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 Read Full Article on GEN Edge >>

// 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). Read Full Article on Fierce Pharma >>
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. Read Full Article on Fierce Biotech >>
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). Read Full Article on Biospace >>
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. Read Full Article on Biospace >>
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. However, weight gain is a late sign of worsening status, and typically does not provide enough advance warning to deliver an effective intervention that can prevent a hospitalization. Until now, patients and their medical teams have not had simple, noninvasive devices to measure earlier signs of worsening fluid status in the home. Read Full Article on Biospace >>
More than a year into a full rebuild, Voyager is casting its clinical sails toward the central nervous system
August 5, 2022 / Voyager Therapeutics / Parkinson’s Disease / Alzheimer’s Disease / Cell & Gene Therapy As it embarks on a new chapter, Voyager will prioritize its three assets indicated for Alzheimer’s, Parkinson’s and a type of amyotrophic lateral sclerosis (ALS), the company announced in its earnings report Thursday. They’re not exactly the easiest diseases to get back on track with, but Sandrock was bullish that the company “has a clear path” to proof-of-concept data and could “further progress these programs in an efficient manner.” Read Full Article on Fierce Biotech >>
Pfizer to Acquire GBT for $5.4B, Adding Sickle Cell Disease Drug and Pipeline
August 8, 2022 / Blood Disorders / Drug Discovery / Pifzer Pfizer said the deal will complement and further enhance its 30-plus year heritage in rare hematology and reinforce its commitment to treating sickle cell disease (SCD), for which GBT has a marketed drug Oxbryta® (voxelotor) approved by the FDA in 2019. Read Full Article on GEN Edge >>

// 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. Read on Law Street >>
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.Read on Fierce Pharma >>
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. Read on Fierce Pharma >>
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. Read on Bloomberg Law >>
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.
Read on Financial Times >>

// 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. Read Full Article on Medical Press >>
AstraZeneca-Daiichi Sankyo’s ADC barrels forward as Keytruda combo data make case for lung cancer use
August 9, 2022 / AstraZeneca / Daiichi / Antiboy-drug conjugates / Merck AstraZeneca and Daiichi Sankyo have delivered more evidence that their TROP2-directed antibody-drug conjugate (ADC) may have a future in non-small cell lung cancer (NSCLC), linking the candidate to a roughly 40% overall response rate when used as part of doublet and triplet combination therapies. Read Full Article on Fierce Biotech >>
Novartis, BeiGene’s PD-1 hits goal in first-line liver cancer. Should Roche worry about Tecentriq?
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. Read Full Article on Fierce Pharma >>
Postoperative Treatment May Improve Glioblastoma Survival Rates
August 9, 2022 / Glioblastoma / Postoperative Treatment The survival rates for glioblastoma are just 25% at one year and plummet to 5% by the five-year mark because of the cancer’s reoccurrence. One of the obstacles of treating glioblastoma is that surgeons can’t always remove every bit of tumor or glioma stem cells that are left in the brain. Now, researchers from the University of Wisconsin-Madison report they have developed a postoperative treatment in mice that may improve survival rates for patients with glioblastoma. Read Full Article on GEN Edge >>
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. He quickly focused on what he called the bacteriophage—the “eater of bacteria”—and whether it could be used to fight infections. Read Full Article on GEN Edge >>
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. Read Full Article on GEN Edge >>
Age Related Increase in Heart Health Risk Linked to Mitochondrial DNA
August 8, 2022 / OMICs / DNA / Mitochondrial Diseases Age is the predominant risk factor for cardiovascular disease (CVD). This is in part due to the snowballing of environmental risk factors over time, and in part due to risk factors acquired later in life, such as mutations that crop up in blood cells through a process called clonal hematopoiesis—where mutations in immature blood cells give rise to populations of mature blood cells carrying identical mutations. Read Full Article on GEN Edge >>
Monoclonal Antibody Prevents Malaria in Clinical Trial
August 5, 2022 / Drug Discovery / Antibodies / Infectious Diseases Results from a Phase I clinical trial have shown that a monoclonal antibody known as L9LS is safe and highly protective in U.S. adults exposed to the malaria parasite. The use of this antibody could be effective in limiting malaria in regions of the world where the disease is endemic. According to the World Health Organization, about 240 million people had malaria in 2020 and about 627,000 of them died. Read Full Article on GEN Edge >>
Study identifies potential targets for treating venous ulcers
August 9, 2022 / Venous Ulcers / New Study The study, which includes the first resource detailing the role of microRNAs in the wound-repair process, shows that aberrant levels of a trio of microRNAs may impair healing in venous ulcers. The findings suggest that drugs targeting these microRNAs could help facilitate healing in patients. Read Full Article on Medical Press >>

// Politics

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. Read Full Article on Biopharma Dive>>
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. Read Full Article on Roll Call >>
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. Read Full Article on Fierce Pharma >>
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. Read Full Article on The Daily Nonpareil >>
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. Read Full Article on New York Times >>