// Biotech and Pharma Therapeutics

J&J puts focus on cancer drugs in push to reach 2025 sales target January 24, 2023 / J&J / Cancer Drugs / Drugmaker – Johnson & Johnson is confident it can reach its target of $60 billion in pharmaceutical sales by 2025, predicting continued growth from its portfolio of cancer and immune disease drugs. The target, first set in late 2021, is 14% higher than the $52.6 billion in drug sales that J&J on Tuesday reported it had earned last year. And reaching it will require faster growth than the 1.7% increase that sales figure represented over 2021’s total. Read Full Article on Biopharma Dive >>
Bristol Myers CMO, others still skeptical about cancer vaccines as BioNTech, Moderna march ahead with I-O partners
January 25, 2023 / JPM 2023 / Cancer Vaccine / Immuno-oncology / mRNA – Moderna and BioNTech recently reported positive early clinical data for their mRNA cancer vaccines in partnership with PD-1/L1 inhibitors. But as over a decade of research has failed to transpire into approved therapies, several biopharma executives remain on the fence about the future for cancer vaccines, while others believe the field is getting closer to finding its sweet spot. Read Full Article on Fierce Biotech >>
J&J trims the edges of its pipeline with the company mum on timing of looming readouts
January 24, 2023 / Johnson & Johnson / Prostate Cancer / Milvexian / Carvykti – The company appeared to cut two phase 1 assets aimed at solid tumors and prostate cancer, respectively, as it presented fourth-quarter earnings results. A spokesperson for the company said that while the two trials are ongoing, the two meds “are not prioritized assets in our development portfolio.” The two culls (PDF) come after the company shed a blood cancer prospect in the third quarter of last year. Read Full Article on Fierce Biotech >>
JPM23: Pfizer, Moderna and more look to combine COVID and flu vaccine markets
January 23, 2023 / JPM 2023 / Moderna / Pfizer / GSK – When Pfizer, BioNTech and Moderna swooped in to save the day with pandemic mRNA vaccines, few people—if any—were thinking about the long-term structure of the COVID-19 vaccine market. Now, as vaccination rates decline and government contracts dry up, that future is becoming clearer. Read Full Article on Fierce Pharma >>
Astellas Plots Near-Term Moves to Execute Long-Term Vision in Gene Therapy
January 24, 2023 / Astellas / Gene Therapy – Astellas sees gene therapy as a key part of its growth and it has been mapping out a strategy in this emerging therapeutic field even amid setbacks to its programs. Its two most advanced gene therapy candidates were under clinical holds for much of last year. A review of preclinical data led to the termination of three other gene therapies for a rare muscular disorder. Read Full Article on MedCity News>>

// 4th Industrial Revolution

Why Patient Portal Usability is Critical to Patient Experience
January 25, 2023 / Patient Experience / Healthcare – Improving patient experience is a primary concern for behavioral health providers today. A positive patient experience can keep clients returning, while a frustrating or confusing experience may push them away. With so much on the line, it’s important to get it right. One of the most powerful tools in a behavioral health practice’s arsenal is a user-friendly, highly functional patient portal. These portals are often clients’ main point of connection to a practice outside of appointments. Read Full Article on HIT Consultant & Biotechnology News >>
Bay Area biotech uses AI to unlock RNA structures — and find new therapies in the process
January 25, 2023 / Bay Area / AI / Healthcare / New Therapies – From Covid-19 vaccines to therapies against a range of deadly diseases, every RNA molecule has a complex 3D shape that controls its function. A new Bay Area biotech is harnessing artificial intelligence to better understand and predict these structures in hopes of developing new therapeutics. Read Full Article on STAT News >>
Nvidia’s AI Tech Designs Proteins Never Seen in Nature, Pointing Way to New Therapies
January 22, 2023 / Nvidia / AI Tech / Evozyne / New therapies – Engineering techniques are already used to design novel proteins with the potential to become new therapies. Nvidia and partner Evozyne have new research showing that their technologies created novel proteins never before seen in nature, doing it faster and with better results. They did it by studying the language of life. Read Full Article on MedCity News>>
Technology could improve pregnancy care for low-income patients — if health systems can pay for it January 24, 2023 / Women’s Health / Pregnancy Care / Low-income Patients – “Even just getting to appointments can be huge trouble,” said Kathryn Marko, an OB-GYN at George Washington, a Washington, D.C.-based health system looking to technology like video calls, apps, and digital blood pressure cuffs to make maternal health care more equitable. For years, Marko has collaborated on that effort with Babyscripts, one of a handful of startups working with health systems to deliver virtual maternal health care specifically for low-income patients, including those on Medicaid, which account for half of all births in the U.S. These companies have struck partnerships with several large health systems to send patients home with their own blood pressure cuffs and apps that keep tabs on their vital signs, weight, mental health, and other factors that can influence maternal health. Read Full Article on STAT News >>
First-in-human implants for Amber Therapeutics’ bioelectrical therapy
January 24, 2023 / Implants / Amber Therapeutics / New Tech – Amber-UI presents a significant opportunity to treat urge and mixed urinary incontinence. Amber Therapeutics – an Oxford University spin off developing next-generation bioelectrical therapies – has announced that the first participants have been implanted with Amber-UI, the company’s proprietary therapy for urge and mixed urinary incontinence (UI). Read Full Article on Pharma Times >>

// Business & Markets

Is Amazon’s RxPass Breaking New Ground in Creating Access to Affordable Drugs? 
January 24, 2023 / Amazon / Affordable Drugs / RxPass – Amazon unveiled a new feature for Prime members Tuesday: RxPass, an Amazon Pharmacy benefit that gives access to generic medications for more than 80 conditions at the price of $5 a month. While it’s making headlines as it always does when the large techs make a move in the healthcare world, reactions were mixed when it came to actually affecting change on the ground. Read Full Article on MedCity News >>
Lilly to boost diabetes drug production with $450M factory investment
January 24, 2023 / Eli Lilly / Novo Nordisk / Investment / Diabetes – Eli Lilly will invest $450 million in a North Carolina manufacturing plant to meet growing demand for its diabetes drugs Mounjaro and Trulicity, the company said Tuesday. The investment in the Research Triangle Park plant will expand filling, device assembly and packaging capacity to help the Indiana-based drugmaker double production of the injectable drugs by the end of 2023. Read Full Article on BioPharma Dive >>
Behind the deal: AstraZeneca’s eagerness for CinCor acquisition revealed in larger initial offer
January 24, 2023 / AstraZeneca / CinCor Pharma / M&A – AstraZeneca kicked off this year’s J.P.Morgan Healthcare Conference in style, announcing a $1.8 billion deal that gave it ownership of CinCor Pharma and its mid-phase hypertension drug baxdrostat. But while Fierce Biotech reported at the time that AstraZeneca was able to exploit CinCor’s deflated share price, that was only part of the story. A Securities and Exchange Commission filing released this week gives far greater insight into the dealings that went into the first major M&A deal of 2023. For starters, it turns out that in May 2021, before an acquisition was even suggested, AstraZeneca had put the feelers out for a potential deal to license baxdrostat alone. Read Full Article on Fierce Biotech >>
Bayer’s oncology business looks to collect $10B in sales by 2030, exec says
January 24 2023 / Bayer / Christine Roth / Nubeqa – Last year, former GSK oncology head Christine Roth took on the challenge of leading the oncology group at German pharma giant Bayer. Her task—to push the company further into the lucrative market—has been bolstered by prostate cancer drug Nubeqa’s second approval and a subsequent sales boost. Read Full Article on Fierce Pharma >>
How a buyer’s sudden withdrawal gave Ipsen a chance to fight for Albireo
January 24, 2023 / M&A / Ipsen / Rare Diseases / Albireo – Ipsen’s near-$1 billion deal for Albireo was among a trio of biopharma acquisitions that opened this year’s J.P. Morgan Healthcare Conference. But Ipsen only got a chance to bid thanks to a sudden withdrawal by another company, and the French pharma fought hard when the opportunity presented itself. Read Full Article on Fierce Pharma >>

// Legal & Regulatory

Lilly turns to nonprofit, not the FDA, to resolve dispute with Novartis over a prescription drug ad
January 25, 2023 / Eli Lilly / FDA / Prescription Drug Ad / Novartis – In a rare move, the BBB National Programs settled a dispute between two big drug companies over a prescription drug ad, suggesting the nonprofit may take a larger role in resolving complaints that might normally be handled by the U.S. Food and Drug Administration. The Dispute began when Eli Lilly challenged some of the information in an ad that Noovartis had run for its Kisqali breast cancer treatment. Read Full Article on STAT News >>
Inhibikase, FDA find common ground to lift hold on Parkinson’s drug
January 25, 2023 / Inhibikase Therapeutics / Parkinson’s Disease / Clinical Hold – After a brief 2.5-month hold, Inhibikase Therapeutics’ Parkinson’s disease therapy is heading back to the clinic. The FDA unexpectedly placed a clinical hold on the midstage therapy IkT-148009 in November 2022, sending Inhibikase’s shares tumbling. The phase 2a trial is now set to get back on track, according to a Wednesday press release. CEO Milton Werner, Ph.D., said in the release that the company is now working quickly to re-open trial sites and get enrollment going, with the restart activities expected to be completed by the end of the first quarter. Read Full Article on Fierce Biotech >>
FDA advisers back Cidara and Melinta’s antifungal treatment
January 25, 2023 / FDA / Cidara / Melinta – Leading up to the advisory committee meeting, the FDA raised concerns about the amount of research Cidara submitted to support approval of its drug. Agency reviewers said they didn’t agree with the company’s proposal to pool data from both Phase 2 and Phase 3 studies and expressed concern that not enough patients had been treated to expose potentially rare side effects. Read on Biopharma Dive >>
What To Look For In A HIPAA-Compliant Vendor
January 24, 2023 / HIPAA / Compliant Vendor – The Health Insurance Portability and Accountability Act (or HIPAA) sets the standards for protecting sensitive patient data. To protect yourself from liabilities, any outside vendor you work with must have the same high standards for compliance that you do. With the stakes so high, choosing a vendor is no small task. Read on MedCity News>>
TheracosBio Drug Approval Puts It in Competition With Blockbuster Diabetes Meds
January 23, 2023 / TheracosBio / Diabetes Meds –A drug that recently won its first regulatory approval as a way of controlling blood glucose in cats is now approved for treating type 2 diabetes in humans. The FDA has approved TheracosBio drug bexagliflozin, used in addition to diet and exercise, as a way to improve the control of blood glucose in adults with type 2 diabetes. Privately held TheracosBio, based in Marlborough, Massachusetts, will market its once-daily pill under the name “Brenzavvy.” Read on MedCity News >>

// Research & Development

Kroger Health launches clinical trial site network
January 25, 2023 / Kroger Health / Clinical Trial / Persephone Biosciences – Kroger Health, the healthcare division of the large grocery chain, announced Tuesday it had launched a clinical trial site network. The company said it will work with trial sponsors, contract research organizations and health systems to conduct clinical trials out of select Kroger pharmacies and clinics. It will also use virtual care and digital health tools to ensure patients stay enrolled in clinical trials. Read Full Article on Mobi Health News >>
SA Health kicks off patient-generated data project with The Clinician
January 25, 2023 / SA Health / Data Project / The Clinician – SA Health, together with the Commission on Excellence and Innovation in Health, will start collecting and analysing patient-reported measures across South Australia through its new programme. The Patient Reported Measures (PRM) programme will support clinical services to deliver “high-quality, patient-centred, and value-driven care” by encouraging patients to report on health outcomes and experiences. Read Full Article on Healthcare IT News >>
Storm reveals STC-15 data for patients with acute myeloid leukaemia
January 25, 2023 / STC-15 / Myeloid Leukaemia / Storm Therapeutics – Storm Therapeutics– a company focusing on ribonucleic acid modifying enzymes (RMEs) for oncology – has presented new data on its candidate, the METTL3 inhibitor, STC-15. The new data in acute myeloid leukaemia (AML) preclinical models was presented at the American Association for Cancer Research (AACR) Special Conference – Acute Myeloid Leukemia and Myelodysplastic Syndrome. Read Full Article on Pharma Times >>
First patients enrolled for Priothera’s mocravimod trial
January 23, 2023 / myeloid Leukaemia / S1P / Priothera – Priothera – a company focused on the development of a sphingosine 1 phosphate (S1P) receptor modulator compound – announced that the first patients have been enrolled in its MO-TRANS phase 2b/3 study evaluating mocravimod. It involves acute myeloid leukaemia (AML) patients undergoing allogeneic haematopoietic cell transplant (HCT). Read Full Article on Pharma Times >>
Promising gene therapy delivers treatment directly to brain
January 24, 2023 / Gene Therapy / Brain-delivered – Rylae-Ann, who lives with her family in Bangkok, was among the first to benefit from a new way of delivering gene therapy — attacking diseases inside the brain — that experts believe holds great promise for treating a host of brain disorders. Her treatment recently became the first brain-delivered gene therapy after its approval in Europe and the United Kingdom for AADC deficiency, a disorder that interferes with the way cells in the nervous system communicate. New Jersey drugmaker PTC Therapeutics plans to seek U.S. approval this year. Read Full Article on STAT News >>

// Politics

Moderna now in the crosshairs of Sens. Warren, Welch over price tag for COVID vaccine
January 25, 2023 / Moderna / Pfizer / Spikevax / COVID-19 – In December, Sens. Elizabeth Warren, D-Massachusetts, and Peter Welch, D-Vermont, sent a letter to Pfizer admonishing the company for a proposed increase in the price of its COVID-19 vaccine for up to $130. Read Full Article on Fierce Pharma >>
Novartis, in SCOTUS filing, argues it was ‘wrongly deprived’ of Gilenya patent after judge’s retirement
January 24, 2023 / Novartis / Gilenya / U.S. Supreme Court / Patent Infringement – In a recent filing (PDF), the company asked the High Court to review a September decision by the U.S. Court of Appeals for the Federal Circuit that went against its favor. That month, a judicial panel overturned a prior win for Novartis and sided with Chinese generics maker HEC Pharm, finding a Gilenya patent invalid and potentially opening the door to competition. At this juncture, Novartis is taking issue with the sequence of events that led to the decision. Read Full Article on Fierce Pharma >>
U.S. Raises ‘Grave Concerns’ Over Mexico’s Anti-GMO Farm Policies
January 23, 2023 / Mexico / Anti-GMO / Farm Policies – U.S. farm and trade officials raised “grave concerns” over Mexico’s agricultural biotechnology policies in meetings with their Mexican counterparts on Monday, as lingering disagreements threaten decades of booming corn trade between the neighbors. Read Full Article on U.S. News >>
Korean biotech lobby expresses concerns over Biden executive order
January 25, 2023 / Korea / Biden / Executive Order – The Korea Pharmaceutical and Bio-pharma Manufacturers Association on Friday sent a written opinion to the US government, in which the business lobby raised concerns over the Biden administration’s executive order aimed at bolstering domestic production of biotechnology and biomanufacturing products. Read Full Article on The Korea Herald >>
Pharma CEOs Among Likely Targets for Democrats’ Subpoenas
January 23, 2023 / Pharma / Democrats / CEOs – Senate Democrats plan their own political counter-programming to House Republicans’ threats of wide-ranging probes into Joe Biden’s administration and his family, taking on issues like corporate tax avoidance and union-busting, issues sure to rankle the GOP. With an expanded majority, they now have the threat of subpoenas to haul corporate executives before their committees, and the pharmaceutical industry, big banks, and social media companies are among the anticipated early targets. Read Full Article on Bloomberg Law >>