// Biotech and Pharma Therapeutics
Novo’s Once-Weekly Insulin Treatment Part of a Transforming T2D Space
September 22, 2022 / Novo / Insulin / Type 2 Diabetes
Insulin icodec differs from other basal insulin products currently on the market, as they require once-daily injections. The trial reached its primary endpoint, with 37% of adults with type 2 diabetes who received the drug achieving an HbA1C less than 7% without having any indications of low blood sugar (hypoglycemia). This compared to 27% of patients receiving insulin degludec at 26 weeks.
GenScript and Gladstone-UCSF Institute of Genomic Immunology Collaborate on Groundbreaking Non-Viral Cell Therapy Study
September 22, 2022 / Cell Therapy / GenScript / Gladstone
A new study, published in Nature Biotechnology, details methods for achieving highly efficient non-viral knock-in using GenScript’s GenExact™ single-strand DNA (ssDNA) modified with Cas9-target sequences (CTS). This method achieved up to ˜90% knock-in efficiency in primary immune cell types.
Stryker receives FDA clearance for OptaBlate™ Bone Tumor Ablation System
September 20, 2022 / Stryker / FDA / OptaBlate
Stryker’s first bone tumor ablation system with patented microinfusion technology offers a reliable solution for people living with painful metastatic tumors
AVROBIO’s Cystinosis Gene Therapy Snags Rare Pediatric Designation
September 20, 2022 / AVROBIO’s / Gene Therapy / Pediatric Designation
The designation provides AVROBIO with a pathway to initiate its own clinical study in cystinosis next year, Essra Ridha M.D., chief medical officer, told BioSpace in an interview. Ridha said the company aims to build on the success seen in a Phase I/II collaborator-initiated study that showed the gene therapy was not only safe and well-tolerated but also generated meaningful efficacy data.
AstraZeneca’s Alexion bet continues to pay off as danicopan improves hemoglobin levels in phase 3
September 16, 2022 / AstraZeneca / Alexion / Ultomiris / Soliris
The interim analysis of the phase 3 ALPHA trial looked at danicopan as an add-on C5 inhibitor therapy for 63 patients with a blood disease called paroxysmal nocturnal hemoglobinuria (PNH) who experience extravascular haemolysis (EVH). EVH occurs when a type of white blood cell normally found in the liver and spleen ingests antibody-coated red blood cells.
// 4th Industrial Revolution
Bayer launches groundbreaking collaboration with Perdue AgriBusiness to reduce carbon emissions and increase sustainability in the food value chain
September 21, 2022 / Bayer / Perdue AgriBusiness / Carbon Emissions
The collaboration – a first-of-its-kind under Bayer’s new ForGround platform – leverages the strengths and scale of both organizations to create a blueprint for businesses to assess their carbon footprint and rapidly scale up their ability to reduce Scope 3 emissions.
Rise of the machines: Novo Nordisk pledges $200M to create first quantum computer for life sciences
September 21, 2022 / Novo Nordisk / Personalized Medicine / Artificial Intelligence / Machine Learning
Big Pharma has long seen the potential for AI and machine learning to accelerate drug development. But Novo Nordisk is going a step further by channeling $200 million toward the creation of a computer that will outrun anything in existence.
3D Medical Printing Systems Market Research Report Analysis And Forecasts To 2030
September 21, 2022 / 3D Medical Printing / 2030
A newly published report titled “3D Medical Printing Systems Market” by Global Market Vision throws light on the industry dynamics and current and future trends that play a key role in determining the business expansion. The report also highlights the key driving factors and restraints that are impacting the growth.
Study looks at impact of artificial intelligence on primary health care
September 22, 2022 / Artificial Intelligence / Healthcare
AI and machine learning (a subfield of AI where patterns are learned from data) encompass a variety of techniques loosely focused on computers performing human-like “intelligent” tasks. AI methods are already used in applications ranging from advanced web search engines (Google) and recommendation systems (Netflix, Amazon) to understanding human speech (Siri and Alexa) and self-driving cars (Tesla).
How a pediatric hospital’s rare disease sequencing system is unlocking the whole genome
September 22, 2022 / Rare Disease Sequencing / Pediatric
Children’s Mercy is claiming to build “the most advanced genomic sequencing system in the world” through its novel use of 5-base sequencing. Since launching three years ago, the system has already provided 1,000 children with rare disease diagnoses based on its genome sequencing.
// Business & Markets
Walgreens To Buy The Rest Of Shields Specialty Pharmacy For $1.37 Billion
September 20, 2022 / Mergers & Acquisitions / Private Equity / Retail
Walgreens Boots Alliance is buying the rest of the specialty pharmacy company Shields Health Solutions for $1.37 billion. The nation’s largest drugstore chain said it has “entered into a definitive agreement to acquire the remaining 30% stake” of Shields from equity holders in the specialty pharmacy company that include private equity firm Welsh, Carson, Anderson & Stowe and the company’s founder and board chairman Jack Shields.
Pfizer to Supply Global Fund Up to 6 Million PAXLOVID™ Treatment Courses for Low-and-Middle-Income Countries
September 22, 2022 / Pfizer / Global Pharma
Pfizer expects supply to be available starting in 2022, pending regulatory authorization or approval and based on country demand. Through Global Fund’s framework and mechanism, eligible countries will be offered treatment courses according to Pfizer’s tiered pricing approach, where all low- and lower-middle-income countries will pay a not-for-profit price while upper-middle-income countries will pay the price defined in Pfizer’s tiered pricing approach.
Puma pounces on failed Takeda drug, snapping up cancer prospect for knockdown price
September 21, 2022 / Puma Biotechnology / Takeda / Small Cell Lung Cancer / Breast Cancer
Puma Biotechnology has gone looking for gems in Takeda’s castoffs, emerging from its rummaging with an aurora kinase A inhibitor that failed a phase 3 trial in 2015 but has since moved the needle in another study. The biotech landed a global license for $7 million upfront plus up to $287.3 million in milestones.
GSK plays the white knight, paying $66M to rescue Spero’s oral antibiotic after FDA rejection
September 22, 2022 / GSK / Spero Therapeutics / Antibiotics / Licensing
GSK is riding to the rescue of Spero Therapeutics’ oral antibiotic prospect, paying $66 million upfront for near-global rights to a drug candidate that needs to undergo another phase 3 trial following its recent rejection by the FDA. Spero is studying the drug as a treatment for complicated urinary tract infections.
Johnson & Johnson opens 400-person R&D facility to strengthen Bay Area presence
September 20, 2022 / Johnson & Johnson / Janssen Pharmaceuticals / San Francisco / Facilities
Johnson & Johnson’s Technology, Innovation and Janssen units have moved in together to a new R&D facility in San Francisco’s Bay Campus. The nearly 200,000-square-foot space will be home to up to 400 employees, more than doubling J&J’s presence in this R&D hot spot.
// Legal & Regulatory
U.S. District Court Rules In Favor of Merck in Sitagliptin Phosphate Patent Lawsuit
September 22, 2022 / Merck & Co. / Patent
Two Merck patents were involved in the suit. The first, U.S. Patent No. 7,326,708, covers the dihydrogen phosphate salt of sitagliptin and is set to expire on Nov. 24, 2026, with pediatric exclusivity extending to May 24, 2027. The second, U.S. Patent No. 8,414,921, covers the co-formulation of sitagliptin and metformin found in JANUMET and is set to expire Jan. 21, 2029, with pediatric exclusivity extending to July 21, 2029. Merck had filed infringement actions against Viatris under both patents, for which Viatris alleged non-infringement and/or invalidity.
J&J’s Talc Solution under Legal Review; Novartis Appeals to Supreme Court
September 21, 2022 / J&J / Supreme Court
A 3-judge panel questioned the legitimacy of Johnson & Johnson’s plan to form a subsidiary company with the purpose of absorbing legal liabilities from talc-related lawsuits. If the court panel deems J&J’s formation of LTL Management an illegitimate business move, the life sciences giant must defend itself in courtrooms across the country against allegations that its talc-based products contributed to the development of cancer in some people.
FDA threatens to clamp down on another PI3K blood cancer drug—this time a full approval
September 22, 2022 / PI3K / Drug Safety / Advisory Committee / Chronic Lymphocytic Leukemia
In a briefing document prepared for an FDA oncology advisory committee meeting set to take place Sept. 23, the FDA laid bare its concerns over the toxicity of Secura Bio’s Copiktra and how the drug could detrimentally impact the life expectancy of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Eli Lilly’s Retevmo wins FDA nod to treat all cancer types with rare RET biomarker
September 22, 2022 / Retevmo / Eli Lily / NSCLC / Biomaker
Two years after blessing Eli Lilly’s Retevmo to treat lung and thyroid cancers caused by a specific biomarker, the FDA has authorized the drug to be used across all tumor types that bear the biomarker. Wednesday’s action by the United States regulator covers all cancers driven by alterations in the rearranged during transfection (RET) gene. Retevmo is available for all locally advanced or metastatic solid tumors, following prior systemic treatment or with no other treatment alternatives.
Nerviano Medical Sciences S.r.l. Announces Collaboration and Option to License Agreement with Merck
September 21, 2022 / Nerviano / License Agreement
NMS-293 is an orally available PARP1 inhibitor, designed to be more PARP1 selective and brain penetrant compared to first generation PARP inhibitors. With its expected lower hematological side effect profile, it has the expected features for potential use not only as single agent but also in combination with DNA-damage accumulating agents in a wide range of tumors.
// Research & Development
Hibernating bears’ ability to regulate insulin narrowed down to eight proteins
September 21, 2022 / Insulin / Washington State University / Hibernating Bears
Feeding honey to hibernating bears helped researchers find the potential genetic keys to the bears’ insulin control, an advance that could ultimately lead to a treatment for human diabetes. Every year, bears gain an enormous amount of weight, then barely move for months, behavior that would spell diabetes in humans, but not for bears whose bodies can turn insulin resistance on and off almost like a switch.
Merck finally gets FDA nod to relaunch HIV trials, but drops preventive therapy plans
September 20, 2022 / Merck & Co. / Clinical Hold / FDA / HIV
The agency slapped the hold on trials of islatravir to both treat and prevent HIV in December 2021, citing decreases in total lymphocyte and CD4+ T-cell counts in some patients receiving the therapy. The previous month, Merck had pumped the brakes on trials of another potential HIV asset, dubbed MK-8507, over similar concerns. Now, the FDA has given the green light to three new phase 3 trials of a 0.75-mg dose of islatravir in combination with Merck’s approved HIV drug Pifeltro.
Immunitas Therapeutics Receives FDA Clearance of IND Application for IMT-009 in Solid Tumors and Hematological Malignancies
September 21, 2022 / FDA Clearance / IMT-009
“We are thrilled to advance IMT-009 to the clinic as we believe it represents a new wave of immuno-oncology agents with transformative potential in both hematological malignancies and solid tumors,” said Seng-Lai “Thomas” Tan, Ph.D., Chief Scientific Officer of Immunitas Therapeutics. “Based on compelling preclinical data demonstrating its dual-action mechanism and non-overlapping biology with other immune checkpoint pathways, IMT-009 will be investigated as a monotherapy and in combination with other cancer therapies.”
Fennec finally pushes drug to prevent chemotherapy-induced hearing loss across the FDA finish line
September 21, 2022 / Fennec Pharmaceutical / FDA / Hearing Loss / Cisplatin
With one drug in its pipeline, 26-year-old Fennec Pharmaceuticals of North Carolina has had a lot riding on its treatment for chemotherapy-induced hearing loss. Finally, 18 years after it was designated as an orphan drug and following two complete response letters, the FDA has approved Pedmark. With news of the green light, Fennec’s share price jumped by 16%. Pedmark becomes the first therapy to prevent cisplatin ototoxicity, the ear poisoning that can affect those who undergo platinum-based chemo.
Period tracking app Flo releases anonymous mode and more digital health briefs
September 16, 2022 / Women’s Health / Digital Health
Period tracking app Flo released its previously announced anonymous mode, which the company said will allow users to access the app without associating their name, email address and technical identifiers with their health data. Flo partnered with security firm Cloudflare to build the new feature and released a white paper detailing its technical specifications. Anonymous mode has been localized into 20 languages, and it’s currently available for iOS users.
Chutes & Ladders—Biden lands on leader for new agency that will oversee ‘cancer moonshot’ initiatives
September 16, 2022 / Chutes and Ladders / FDA / Scorpion Therapeutics / Sanofi
President Joe Biden has landed on a leader for his new federal biotech agency aimed at overseeing his ambitious “cancer moonshot” initiatives. Renee Wegrzyn, a veteran of the federal government and current executive at Ginkgo Bioworks, is slated to be the inaugural director of the Advanced Research Projects Agency for Health (ARPA-H). ARPA-H is the manifestation of Biden’s larger ambitions for reducing the cancer death rate—shaving it 50% over the next 25 years, to be exact.
Biden admin says Supreme Court should reject Amgen’s petition to take up Repatha patent case
September 22, 2022 / Amgen / Regeneron Pharmaceuticals / Sanofi / US Supreme Court
In a Supreme Court brief (PDF), the U.S. Solicitor General, Elizabeth B. Prelogar, said Amgen’s petition “should be denied.” After reviewing the case, the government backed an appeals court’s ruling that Amgen’s patent claims at issue are invalid because “undue experimentation” would be required to “enable their full scope.” Amgen first sued Sanofi and Regeneron back in 2014, alleging patent infringement when the partners sought approval for their PCSK9 cholesterol drug Praluent.
The Biden Biotech Boom Is About To Send This 6.8% Dividend Soaring
September 17, 2022 / Biden / Politics /
Some major—and almost totally ignored—news from Washington, D.C., is about to upend the biotech world, turning America into “the world’s pharmacy” in short order—and giving us a chance to buy a solid 6.8% dividend for just 91 cents on the dollar. That might sound hard to believe for woebegone biotechs, which have fallen further than the S&P 500 this year, going by the performance of the benchmark iShares Biotechnology ETF (IBB IBB -1.1%).
Government forms committee to regulate marketing practices of pharma companies
September 21, 2022 / Government / Regulate Marketing / Promoting Drugs and Products
The government has constituted a high-level committee to hammer out a legal mechanism to address the issue of pharmaceutical companies giving inducements for promoting their drugs and products. The five-member committee chaired by Dr VK Paul, NITI Aayog member (health) will also review various other issues pertaining to the Uniform Code of Pharmaceutical Marketing Practices (UCPMP).