Mon.May 01, 2023

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A CEO’s quest to solve a 400-year-old medical mystery — and he’s also a patient

PharmaVoice

The CEO of Ventoux Biosciences has the disease that his company is aiming to treat, and it's driving him to find better medications.

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Survey: Anti-LGBTQ legislation takes alarming mental-health toll on queer youth

STAT

Across the U.S., anti-LGBTQ legislation — and especially anti-trans legislation — is limiting queer youth’s access to everything from bathrooms to gender-affirming surgery. A new national survey from the Trevor Project paints a stark picture of the mental-health toll of these forces: LGBTQ youth consider and attempt suicide at alarmingly high rates, and nearly one-third say their mental health was poor “most of the time or always” due to anti-LGBTQ policies and

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Emalex aims at a first-in-class breakthrough for Tourette syndrome

PharmaVoice

With its phase 3 candidate, the biotech believes it can move the field beyond antipsychotics to a more effective approach.

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In a small new study, scientists working on an AI ‘brain decoder’ inch closer than ever to reading minds

STAT

Alexander Huth settled into an MRI machine in the Austin, Texas, neuroscience research building where he worked, a cozy blanket draped over him to stave off the chill from the machine’s magnet, and soundproof earbuds to drown out its drone. The sound in the earbuds, though, came through loud and clear. “From the New York Times and WBUR Boston, this is ‘Modern Love,’” the podcast began.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Myths? Busted! Debunking Common Pharmacy Myths

Pharmacy Is Right For Me

There are a lot of misconceptions and myths about careers in pharmacy and we’re on a mission to change that! Let’s debunk some of the most common myths about pharmacy careers. Pharmacy Myth 1: Pharmacists only work in retail settings. Pharmacists work in a wide variety of practice settings and we highlight a portion of them on our Novel Practice Settings page.

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STAT+: Beyond Wegovy and Ozempic: Biotechs vie for piece of red-hot weight loss market with novel strategies

STAT

This is part of a series about new obesity drugs that are transforming patients’ lives, dividing medical experts, and spurring one of the biggest business battles in years. Read more about  The Obesity Revolution. For nearly a decade, Novartis aggressively pursued a drug candidate for muscle disorders, testing it on people with chronic inflammation, elderly people with frailty, hip surgery patients, and other groups.

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More Trending

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Opinion: The apparent poisoning of schoolgirls is just one part of Iran’s health crisis

STAT

On the first day back to school in April, after time off to celebrate the Persian New Year, students in Iran were greeted with another apparent chemical attack. This was just the most recent in a monthslong series of reports of students, in particular girls, apparently being poisoned. These chemical attacks , as they have been called, began in November 2022 and have escalated in recent months.

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New PhRMA Ad Campaign Sheds Light on PBM Abuses

PhRMA

The Pharmaceutical Research and Manufacturers of America (PhRMA) today launched a new ad campaign that continues to shed light on the role of pharmacy benefit managers (PBMs) in driving up health care costs and denying coverage of lifesaving medicines.

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STAT+: Sam Waksal and Jeremy Levin plot ‘the turnaround story of the century’

STAT

Over glasses of Chablis at Fleming by Le Bilboquet in Manhattan, two longtime friends and biotech lifers hashed out the deal that will bring their wending and colorful careers back together after three decades. Jeremy Levin, the professorial executive who has become one of the industry’s loudest voices on matters of social justice, is getting back into business with Sam Waksal, a hit-making drug developer with a gift for eloquence and a biography that doubles as biotech’s great unp

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Americans want state policymakers to lower out-of-pocket costs

PhRMA

Too many Americans are struggling to access and afford their health care. While policy debates about how to address these issues can seem never ending, American adults largely agree on what state policymakers should be doing to help deliver relief to patients at the pharmacy counter.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Hospitals that denied emergency abortion broke the law, feds say

STAT

WASHINGTON — Two hospitals that refused to provide an emergency abortion  to a pregnant woman who was experiencing premature labor put her life in jeopardy and violated federal law, a first-of-its-kind investigation by the federal government has found. The findings, revealed in documents obtained by The Associated Press, are a warning to hospitals around the country as they struggle to reconcile dozens of new state laws that  ban or severely restrict abortion  with a federa

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Ovid partners with Waksal startup to develop drugs for rare brain disorders

BioPharma Dive

Founded by Sam Waksal, Graviton Biosciences is developing drugs that block an enzyme called ROCK2, which drew the interest of neurology-focused Ovid.

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Expansive investigation into Stanford president’s past research will be ‘substantially complete’ by mid-July

STAT

An investigation by a special committee of Stanford’s board of trustees into alleged scientific misconduct by Marc Tessier-Lavigne , the university’s president and a prominent neuroscientist, has involved “hundreds of hours of meetings and witness interviews” and will be “substantially complete” by mid-July, the panel said Sunday.

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Initial launches with $75M and a new idea for targeting problematic proteins

BioPharma Dive

The company was co-founded by, among others, Jamie Cate, husband of CRISPR pioneer Jennifer Doudna, and Kevan Shokat, a chemical biologist whose previous work helped lead to KRAS-targeting cancer drugs.

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Travere Therapeutics drug, approved for one rare and deadly kidney disease, fails in study of another

STAT

SAN DIEGO  — Travere Therapeutics, a biotech focused on treating rare diseases, on Monday announced that a Phase 3 trial of an experimental treatment for focal segmental glomerulosclerosis, a rare and deadly kidney disease, failed to improve kidney function. In the 371-person study, half of patients were randomly assigned to receive the drug, known as sparsentan, while the other half received irbesartan, a blood pressure treatment used as a control.

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Astellas Pharma agrees to buy Iveric bio for about $5.9bn

Pharmaceutical Technology

Astellas Pharma has entered into a definitive agreement to buy US-based biopharmaceutical company Iveric bio, in a deal valued at nearly $5.9bn. Under the deal terms, the company, through Astellas US Holding’s wholly owned subsidiary Berry Merger Sub, will acquire all the outstanding Iveric Bio shares for $40.00 in cash for each share. Both the companies’ Boards of Directors have unanimously approved the deal.

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STAT+: Astellas acquires Iveric Bio for $5.9B, entering competition to treat common cause of vision loss

STAT

Japanese drugmaker Astellas said late Sunday it would acquire eye drug developer Iveric Bio for $5.9 billion, betting heavily on a prospective treatment for a form of vision loss that affects around 1 million people in the U.S. Iveric had been competing with another biotech, Apellis Pharmaceuticals, to develop the first therapy for geographic atrophy, a disease of aging in which parts of the retina waste away, forming irreversible blind spots.

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Astellas to acquire eye drug developer Iveric Bio for $5.9B

BioPharma Dive

The deal is a sizable bet on an experimental geographic atrophy drug now under review that could compete with a medicine from Apellis Pharmaceuticals.

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STAT+: Most of Canada’s public research universities get bad grades for ensuring access to drugs they discover

STAT

Despite significant public funding, most of the 15 largest public research universities in Canada failed to enact policies that would ensure medicines that emerged from their laboratories would be equally accessible around the world, according to a new analysis. Half of biomedical licensing agreements established at the universities during a recent two-year period did not insist on retaining exclusive control over underlying technologies.

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Bill C-47 introduces patent term adjustment: Proposed term to run concurrently with term of Certificate of Supplementary Protection

Pharma in Brief

On April 20, 2023, the federal government tabled legislation ( Bill C-47 ) that would amend the Patent Act to bring, for the first time, a system of general patent term adjustment ( PTA ) into Canada. Canada is required under the Canada-United States-Mexico Agreement ( CUSMA ) to adopt a PTA system by 2025. The PTA system is intended to compensate patentees for “unreasonable delays” by the patent office in issuing a patent.

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Babies born to opioid users have shorter hospital stays with parental involvement: study

STAT

Babies born to opioid users had shorter hospital stays and needed less medication when their care emphasized parent involvement, skin-to-skin contact and a quiet environment, researchers reported Sunday. Newborns were ready to go home about a week earlier compared to those getting standard care. Fewer received opioid medications to reduce withdrawal symptoms such as tremors and hard-to-soothe crying, about 20% compared to 52% of the standard-care babies.

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FDA Accelerates Approval for Qalsody, the First Treatment Targeting Genetic Cause of ALS

PharmExec

Biogen Inc. announced the approval, a groundbreaking treatment for adults with ALS, offering hope to patients suffering from SOD1-ALS, a rare and fatal genetic form of the disease.

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STAT+: Carbon Health blasts a major insurer in rare public dispute over coverage

STAT

OAKLAND, Calif. — Primary care startup Carbon Health blasted health insurer Elevance on Monday for paying it less than competitors and for also refusing to process out-of-network claims — a rare public escalation of the behind-the-scenes disputes between providers and payers. San Francisco-based Carbon said that Elevance — formerly known as Anthem, which operates the Anthem Blue Cross plan in California — had refused to increase its payment rate in the state beyond 20

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What You Need to Know about Celiac Disease

Putting Patients First Blog

What You Need to Know about Celiac Disease May 1, 2023 By: Alice Bast, President & Chief Executive Officer, Beyond Celiac May is Celiac Awareness Month. In celebration, Beyond Celiac invites everyone to learn more about this serious autoimmune disease and help those currently suffering. Celiac disease is an autoimmune disorder that affects approximately 1% of the US population, or over 3.1 million people.

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STAT+: Pharmalittle: More biotechs are betting on obesity; Pfizer RSV vaccine faces hurdles in low-income countries

STAT

Good morning, everyone, and nice to see you again after a week-long respite in which we toured historical sites, gazed at the countryside, and walked with llamas (please write us for details). Of course, we hope your own weekend respite was relaxing and invigorating, because that oh-so familiar routine of phone calls, online meetings, and deadlines has returned.

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Bristol Myers Squibb boosts CAR T therapy manufacturing capabilities

European Pharmaceutical Review

After agreeing to acquire a US-based manufacturing facility and its operations from Novartis, Bristol Myers Squibb (BMS) adds in-house production of viral vectors to its capabilities. The facility in Libertyville, Illinois has the resources to produce viral vectors for BMS’s two CAR T-cell therapies, Abecma (idecabtagene vicleucel) and Breyanzi. This move will support the expansion of the company’s global cell therapy manufacturing network.

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Improved gene editing method could power the next generation of cell and gene therapies

World Pharma News

A new approach to the genetic engineering of cells promises significant improvements in speed, efficiency, and reduction in cellular toxicity compared to current methods. The approach could also power the development of advanced cell therapies for cancers and other diseases, according to a study from researchers in the Perelman School of Medicine at the University of Pennsylvania.

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Teva, MedinCell receive FDA approval for Uzedy to treat schizophrenia

Pharmaceutical Technology

Teva Pharmaceuticals and MedinCell have received approval from the US Food and Drug Administration (FDA) for Uzedy (risperidone) extended-release injectable suspension to treat adult patients with schizophrenia, a chronic, progressive, and severely debilitating mental health disorder. Developed using MedinCell’s SteadyTeq copolymer technology, Uzedy is the first subcutaneous, long-acting formulation of risperidone.

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US FDA asks Sun Pharma to stop trial on dermatological drug citing potential of blood clots

Express Pharma

The US Food and Drug Administration (FDA) has asked Sun Pharmaceutical Industries to stop trials on one dose of a dermatological drug due to the potential of blood clots, informed a company statement. The company said, “The agency has placed the IND on partial clinical hold, due to the potential for thrombotic events, and are requiring that subjects currently on the 12 mg BID dose in the OLE studies to discontinue that dose.

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China’s NMPA grants priority review status for Ocumension’s Zerviate NDA

Pharmaceutical Technology

Nicox’s Chinese partner Ocumension Therapeutics has secured priority review status for the New Drug Application (NDA) for Zerviate (cetirizine ophthalmic solution), 0.24%, from China’s National Medical Products Administration (NMPA). This will expedite the regulatory approval process as well as the launch of Zerviate in the country, expected next year.

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Bristol-Myers Squibb Files Patent Infringement Complaint Against AstraZeneca Regarding Anti-PD-L1 Antibody Product

Big Molecule Watch

On April 25, 2023, Bristol-Myers Squibb (“BMS”) filed a complaint in the District of Delaware against AstraZeneca related to AstraZeneca’s anti-PD-L1 antibody product, IMFINZI (durvalumab), alleging willful infringement of U.S. Patent No. 9,402,899 (“the ’899 patent”). BMS alleges that the ’899 patent covers “Nobel Prize winning methods of treating cancer” by using “an antibody to inhibit the interaction between PD-1 and PD-L1 to treat cancer in patients.

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CIRM grants funds to Ossium Health for OSSM-007 development

Pharmaceutical Technology

The California Institute of Regenerative Medicine (CIRM) has awarded $3.46m Clinical Stage Research Programme (CLIN1) grant to Ossium Health for advancing OSSM-007 development to treat steroid-refractory acute graft versus host disease (GVHD). OSSM-007 is the interferon-gamma primed mesenchymal stem cell product of Ossium Health. The grant will help in expediting pre-clinical and manufacturing activities of the product.

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Improved gene editing method could power the next generation of cell and gene therapies

World Pharma News

A new approach to the genetic engineering of cells promises significant improvements in speed, efficiency, and reduction in cellular toxicity compared to current methods. The approach could also power the development of advanced cell therapies for cancers and other diseases, according to a study from researchers in the Perelman School of Medicine at the University of Pennsylvania.

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Transforming Healthcare Data to Precision Medicine

PharmExec

A modern healthcare ecosystem involves various stakeholders and many forms of complex data. Collaborations and a range of advanced approaches are essential to providing more uniform and complete healthcare to patients.

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US FDA declines to approve Ascendis Pharma’s TransCon PTH NDA

Pharma Leaders

The US Food & Drug Administration (FDA) has declined to approve Ascendis Pharma’s New Drug Application (NDA) for TransCon PTH (palopegteriparatide) to treat hypoparathyroidism in adult patients. The regulator , in its complete response letter (CRL), mentioned concerns regarding the manufacturing control strategy for variability of delivered dose in the TransCon PTH drug/device combination product.