// Biotech and Pharma Therapeutics
Boehringer Ingelheim embraces dual-pricing tactic with launch of unbranded Humira biosimilar
After debuting its branded Humira biosim Cyltezo in July, Boehringer has launched an unbranded copycat of the inflammatory disease drug, simply called adalimumab-adbm injection, which will be sold at an 81% discount to Humira. By comparison, BI’s Cyltezo carries a 5% discount on the branded med.
Sandoz spins out of Novartis as standalone generic drugmaker
Sandoz immediately becomes one of the largest standalone generic drugmakers in the world, competing with the likes of Teva Pharmaceutical and Viatris. Last year, Sandoz brought in more than $9 billion in revenue, with about one-fifth coming from biosimilars, or copycat versions of biologic drugs.
Signant Health Launches Signant Biotech to Accelerate and Streamline Clinical Development for Emerging Biopharmaceutical Organizations
Signant Biotech is anchored by a unified technology platform consisting of fully integrated EDC, eCOA, eConsent, RTSM, and telemedicine solutions. Delivered in conjunction with Signant’s scientific and regulatory expertise, attentive project delivery teams who are well-versed in the needs of smaller sponsor organizations, as well as Signant’s global operational reach, the technology platform and accompanying services enable customers to scale from local to multinational studies.
J&J, retreating from infectious disease, partners with Sanofi on E. coli vaccine
J&J brought in Sanofi as it moves away from infectious disease work. In March, the company abandoned a high-profile attempt to develop a vaccine for respiratory syncytial virus. That followed January’s announcement of disappointing results for an HIV vaccine.
Eurofins CDMO Alphora Inc. (Canada) Announces the Launch of its Biologics Initiative focusing on mAbs and Therapeutic Proteins
Eurofins CDMO Alphora Inc. is pleased to announce the launch of its Biologics initiative, as part of its vision to diversify and grow within the contract development and manufacturing industry in North America. The multiphase initiative aims to establish a facility at the 2070 Hadwen site within the Sheridan Research Park campus in Mississauga, ON, Canada. The first phase of the project, scheduled for completion by December 2023, is a 3,300 square foot pilot scale facility focused on mammalian cell culture (mAbs) and therapeutic proteins, providing non-cGMP process development and up to 200L scale production.
// 4th Industrial Revolution
Women’s and Children’s Health Network launches Australia’s first virtual gynaecological service
The virtual service catering to gynaecological concerns is said to be a first in Australia. This allows women experiencing pain or bleeding in early pregnancy to no longer present and wait in an emergency department “during such a challenging time,” SA Health said in a statement.
Atropos Health Launches Gen AI App with Direct Chat-to-Database for Health Systems
Atropos Health’s GENEVA OS and ChatRWD were created for clinicians, researchers, and drug developers to address the global evidence gap and expedite decision-making. These tools can now be used alongside Atropos’ existing solutions, including the Green Button Informatics Consult Service, Atropos Evidence Network, and Atropos Evidence Library.
Transforming Healthcare With Generative AI
Generative AI is selling itself to emerge as the new frontier in the horizon for the booming healthcare industry. Highlighting some of the significant developments in this technology space, this article has a few Indian leaders voicing their opinions on exploring Generative AI to progress their businesses and services.
Without the right IP protections, we might say goodbye to our biotech innovation sector
The United States lost its once-dominant position in semiconductor research and manufacturing thanks largely to shortsighted policy decisions. Thankfully, Congress, rightfully alarmed over the potential economic and national security implications, passed last year’s bipartisan CHIPS Act — which invested $52 billion in domestic semiconductor research and manufacturing — to regain a foothold.
Making the Case for AI in Patient Experience and Education
As a physician, I’m captivated by artificial intelligence’s (AI) potential to revolutionize care, while simultaneously acknowledging the apprehensions that accompany such advancements — in particular the more topical large language models (LLMs) and generative AI.
// Business & Markets
Eli Lilly Jumps Into Radiopharmaceuticals via $1.4B Point Biopharma Acquisition
Acquiring Point Biopharma gives Eli Lilly a pipeline of radiopharmaceuticals, including one for prostate cancer that could rival Novartis’s Pluvicto. The deal comes ahead of an expected Phase 3 data readout for that Point therapeutic candidate.
Congestive Heart Failure Drugs Market Predicted to Double by 2031, Bolstered by Technological Advancements and Key Industry Developments
The congestive heart failure (CHF) drugs market is projected to experience significant growth over the next decade, with its value expected to more than double from $6.7 billion in 2022 to $13.5 billion by 2031, according to a report by Transparency Market Research Inc. This expansion represents a compound annual growth rate (CAGR) of 7.6% between 2023 and 2031.
ASX healthcare stock Noxopharm explodes 165% on FDA news
Investors have been scrambling to buy the company’s shares this morning after its CRO-67 preclinical drug candidate for the treatment of pancreatic cancer was given a major boost from the US Food and Drug Administration (FDA).
Regeneron, Intellia target neurological diseases in expanded gene editing deal
Regeneron Pharmaceuticals and Intellia Therapeutics are again expanding a longstanding research partnership, this time with a focus on creating genetic medicines for neurological and muscular diseases.
AbbVie acquires Parkinson’s drug in latest biotech buyout
The acquired company, Mitokinin, has focused on an enzyme called PINK1, which research indicates can protect neurons from damage and death by keeping the mitochondria running properly.
// Legal & Regulatory
Johnson & Johnson gets a talc win as New Jersey court erases $223M jury award
After being denied in its second attempt to resolve talc lawsuits through a bankruptcy ploy, Johnson & Johnson is doubling down on another tactic it has used to negate some of the 30,000-plus claims it faces.
Lilly eczema drug turned back by FDA over manufacturing
Lilly bet on lebrikizumab when it bought the drug’s owner Dermira for $1.1 billion. At the time of the buyout, Phase 3 testing had just begun on the antibody treatment, which works by binding to a cytokine called IL-13.
ICER weighs in on Medicare price negotiations with new appraisals of BMS’ Eliquis, J&J’s Xarelto
As a new age of price negotiations dawns in the U.S., drug cost watchdogs at the Institute for Clinical and Economic Review (ICER) are laying out their stance on two popular blood thinners.
CDC proposes new antibiotics policy aimed at reducing STIs
In a guidance document published Monday in the Federal Register, the CDC is seeking input on its proposal that health providers offer gay and bisexual men who have sex with men, as well as transgendered women, access to a common antibiotic, doxycycline, that they could take after having had unprotected sex to lower their risk of acquiring chlamydia, gonorrhea, or syphilis. Doxycycline is in the tetracycline family of antibiotics.
AstraZeneca ponies up $425M to settle US lawsuits over Nexium, Prilosec
Four months after GSK settled a key case in California over its heartburn medication Zantac, AstraZeneca is following suit, agreeing to resolve personal injury claims over its heartburn drugs Nexium and Prilosec.
// Research & Development
Rare mutation may counteract “Alzheimer’s gene”
One genetic variant in particular — called APOE-e4 — is strongly tied to the brain disease. Having one copy makes a person 2-3 times more likely to develop Alzheimer’s, while having two copies (one from each parent) increases the risk by 8-12 times.
J&J’s Spravato Bests Quetiapine in Phase III Head-to-Head Depression Study
Johnson & Johnson’s nasal spray Spravato (esketamine) CIII outperformed extended-release quetiapine at inducing remission in patients with treatment-resistant depression, the company announced Wednesday at the same time the results were published in The New England Journal of Medicine.
Mayo Clinic, Phenomix Awarded First Patent for Obesity Phenotyping
The technology underlying the patent was developed by Phenomix’s founders at Mayo Clinic, Andres Acosta, M.D., Ph.D., and Michael Camilleri, M.D., D.Sc. The patent is assigned to Mayo Clinic and exclusively licensed to Phenomix to develop, manufacture and market obesity phenotyping tests including the two MyPhenomeTM Tests launched by the company earlier in the year.
Biotechs favor natural psychedelics due to possible ‘entourage effect’
While more research is needed around this so-called “entourage effect,” biotechnology companies also see other potential benefits from using plant-sourced psychedelic compounds in their research programs, such as intellectual property (IP) opportunities and consumer preference for natural products.
FDA Puts Innate’s Lymphoma Trials on Partial Hold After Patient Death
The FDA has placed a partial clinical hold on two of Innate Pharma’s trials assessing its investigational antibody lacutamab following one patient death, the company announced Thursday.
// Politics
Amgen, AbbVie, Gilead, Merck and more form coalition to push back on FTC’s M&A reforms
The Federal Trade Commission (FTC) recently came up short in its attempt to derail Amgen’s $27.8 billion acquisition of Horizon Therapeutics. But there is still considerable concern in the biopharma industry about increased government scrutiny of M&A activity.
One judge’s ruling threatens American scientific research
Judge Matthew Kacsmaryk of the Northern District of Texas ruled in April to suspend the Food and Drug Administration’s (FDA) approval of mifepristone, an abortion pill that has been used safely and effectively for more than 20 years. This decision, if upheld by the Supreme Court next week, could have enormous repercussions for the future of scientific research.
Biden announces manufacturers of all drugs selected for Medicare price negotiations have agreed to participate
President Joe Biden announced Tuesday that the manufacturers of all of the first 10 prescription drugs selected for Medicare’s first price negotiations have agreed to participate, clearing the way for talks that could lower their costs in coming years and give him a potential political win heading into next year’s election.
Major Supreme Court cases to watch in the new term
Looking at an upcoming Supreme Court term from the vantage point of the first Monday in October rarely tells the full story of what lies ahead, but the docket already includes major cases concerning the intersection between the First Amendment and social media, gun rights, racial gerrymandering and the power of the executive branch when it comes to regulation.
US Supreme Court Critical of Challenge to Consumer Financial Watchdog
A payday lending group, which filed the challenge back in 2018, argues that Congress violated the Constitution by letting the bureau draw as much money as it needs (up to a cap it has never hit) from the Federal Reserve. The CFPB has long been a target of conservatives who see it as a symbol of an unaccountable and overreaching federal bureaucracy.