Mon.Apr 15, 2024

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STAT+: Can investing in infectious disease pay off? Vir Biotechnology’s tightrope walk shows it’s a struggle

STAT

Nearly a decade ago, venture capitalist Bob Nelsen called industry veteran Vicki Sato to pitch her on launching a large company dedicated to tackling the world’s worst pathogens. “This is a crazy idea,” Sato said. Nelsen, managing director of ARCH Venture, had made a name and fortune off crazy ideas, but generally it was the science that sounded crazy: engineering cells to cure cancer, finding drugs to slow aging.

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Traditional gene therapies are uber-niche. Ocugen hopes to change that.

PharmaVoice

The biotech is developing a ‘gene-agnostic’ approach to expand the patient pool for gene therapies.

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Trending Sources

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STAT+: Thanks to CVS, a biosimilar version of AbbVie’s Humira is grabbing huge market share

STAT

The number of new prescriptions written for biosimilar versions of the Humira rheumatoid arthritis treatment, one of the best-selling medicines in the U.S., surged to 36% from just 5% during the first week of April, thanks to the expanding reach that CVS Health has over the prescription drug market. The big jump was attributed to one particular biosimilar called Hyrimoz, which is manufactured by Sandoz, a unit of Novartis that is a leading supplier of generic and biosimilar medicines.

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Where the GLP-1 weight loss market goes will depend on data

PharmaVoice

As GLP-1s expand into new disease categories, their impact could be enough to overtake leading cardiovascular drugs.

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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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Opinion: ADHD is often overlooked in females. They need help, too

STAT

Boys aren’t the only people who develop attention-deficit/hyperactivity disorder (ADHD). It also affects girls and young women and adults of both genders. Yet females with ADHD are chronically underdiagnosed and undertreated. Individuals with this condition die about 10 years earlier than those without it. They are also up to three times more likely to experience a variety of nonfatal negative life events, such as serious car accidents, unintended teen pregnancy, episodes of anxiety and d

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Psychedelic treatments on cusp of approval, but questions remain

pharmaphorum

Psychedelic treatments for conditions like PTSD using substances like MDMA are on the brink of approval, but there are still unanswered questions surrounding their effectiveness and potential risks. Learn more here.

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More Trending

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Regeneron launches $500m venture capital arm

pharmaphorum

Regeneron has formed a corporate venture capital unit with $100 million a year to invest over the next five years in “biopharmaceutical, healthcare, and health technology” start-ups.

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STAT+: Ultragenyx reports early success with Angelman syndrome drug, backing up 2022 acquisition

STAT

Ultragenyx has found early success with its experimental treatment for the rare disease Angelman syndrome, supporting the company’s decision to acquire its development partner two years ago. Ultragenyx is one of the few companies developing a treatment for Angelman syndrome , a genetic condition that causes delayed development, problems with speech and balance, mental disability, and sometimes seizures.

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Ultragenyx says Angelman therapy is working, but safety questions remain

BioPharma Dive

Treatment appeared to result in functional and cognitive gains in people with the neurological disorder. Three participants experienced lower extremity weakness, however.

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STAT+: Cerebral to pay $7 million fine and limit health data use for ads under federal order

STAT

Telehealth company Cerebral will limit the consumer health data it uses for advertising purposes under a new order announced by the Federal Trade Commission Monday. Cerebral, a startup best known for dispensing counseling services and prescriptions for conditions like anxiety and depression, has also agreed to pay $7 million to resolve charges that it disclosed customers’ personal health information to third parties for ads, and that it did not honor its promise to make cancellation easy

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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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Activist hedge fund seeks big shake-up at Novavax

pharmaphorum

Shah Capital has fired a broadside at the management team of Novavax, seeking a change in leadership at the vaccine company and the appointment of two handpicked directors to the board. In an open letter, the hedge fund accuses Novavax’s leadership of squandering its “many significant competitive advantages and sizeable market opportunity” due to “self-inflicted problems” under the current team led by chief executive John Jacobs.

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STAT+: Pharmalittle: We’re reading about a J&J cough syrup, a Pfizer and Moderna patent suit, and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was invigorating and refreshing, because that oh-so familiar routine of phone calls, online meetings, and rushing about has predictably returned. But what can you do? The world, such as it is, continues to spin. So time to give it a nudge in a better direction with a cup or three of stimulation.

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After ph3 win, Roche eyes earlier use of Columvi in DLBCL

pharmaphorum

Roche’s CD20xCD3 bispecific antibody Columvi has improved survival when used as a second-line therapy for diffuse large B-cell lymphoma (DLBCL) in a phase 3 trial, setting up regulatory filings for earlier use of the drug in the treatment pathway.

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Medicare expects a big spike in spending on Leqembi

STAT

You’re reading the web version of Health Care Inc.,  STAT’s weekly newsletter  following the flow of money in medicine.  Sign up  to get it in your inbox every Monday.  Anne Klibanski on the Dana-Farber split Mass General Brigham didn’t foresee the breakup with Dana-Farber Cancer Institute. But there won’t be any texts begging Dana-Farber to come back.

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Francis Crick researchers reveal pathways linking intestinal inflammation and colitis

Pharma Times

Affecting over 500,000 people in the UK, IBD comprises Crohn’s disease and ulcerative colitis

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A two-decade bet on Seagen pays off

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hi there, Meghana here — a little wistful about the departure of the illustrious Damian Garde but extremely excited about a fantastic newsletter co-author we’ll introduce soon.

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Pulmcrit wee: The cutoff razor

EMCrit Project

A razor is a rule of thumb that is helpful, although it isn't always correct. In medicine we're familiar with Occam's razor (the rule of parsimony). The cutoff razor states: if a continuous variable is dichotomized using a cutoff, then values near the cutoff provide little information. A simple illustration of the cutoff razor is […] EMCrit Project by Josh Farkas.

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Advancing medicine requires more secure supply chains

pharmaphorum

The advancement of medicine is dependent on secure pharmaceutical supply chains. Discover why ensuring the security of these chains is crucial for the development and distribution of life-saving medications.

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Keeping cleanrooms clean: Choosing the right laboratory equipment is key

BioPharma Dive

Because live cell and tissue products are extremely sensitive to contamination from microorganisms, viral particles or other airborne impurities, research and manufacturing involving these materials needs to be conducted in a cleanroom environment.

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Healthware re-launches as Eversana Intouch full service affiliate

pharmaphorum

Life sciences service provider (and pharmaphorum parent company) Eversana has completed the integration of Healthware Group, the Italy-based global agency and consultancy it acquired in October. The group will now be known as Eversana Intouch Healthware and will operate as Eversana’s sixth full-service affiliate.

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The growing role for cfHPV-DNA testing in OPSCC therapeutic development

BioPharma Dive

Learn about why access to robust biomarkers such as cfHPV-DNA is pivotal in determining eligibility, assessing treatment response and detecting recurrence early to improve patient outcomes.

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Study warns of chronic kidney disease timebomb

pharmaphorum

Up to one in six people in eight industrialised nations could be suffering from chronic kidney disease (CKD) by 2032, with dire consequences for “patients, [the] planet, and economies,” says a new study.

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Roche reports survival data for new dual-acting lymphoma drug

BioPharma Dive

The results could give Roche’s Columvi an edge over a rival medicine from AbbVie and Genmab, while Regeneron awaits an approval of its own therapy.

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How is Oracle technology helping CROs enable pharma to get trials up and running?

Outsourcing Pharma

Michael Fronstin, global head of client partnership and commercialization at the company said the combination of Oracleâs life sciences expertise and platform technology help CROs win more business and run trials more efficiently.

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Fujifilm plans $1.2 billion investment in major US manufacturing facility

European Pharmaceutical Review

FUJIFILM Corporation is planning to invest $1.2 billion to expand the planned FUJIFILM Diosynth Biotechnologies manufacturing facility in Holly Springs, North Carolina, US. This news follows the organisation’s announcement of a $2 billion investment in the facility in March 2021. This additional financial boost totals the investment to over $3.2 billion, FUJIFILM confirmed.

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NHS opens national booking system for spring Covid-19 vaccinations

The Pharmacist

The NHS national booking system for spring Covid-19 vaccination bookings via pharmacies in England is now open. Those eligible to book appointments are able to do so for next week. They include adults aged 75 or over as of 30 June 2024, residents in care homes for older adults, and individuals who are immunosuppressed. The […] The post NHS opens national booking system for spring Covid-19 vaccinations appeared first on The Pharmacist.

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Nine UCL researchers secure £560m in research funding from ERC

Pharma Times

Approximately 14% of the competition-submitted proposals were selected to receive funding

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Diabetes drug shows potential in treating Parkinson’s disease

The Pharmacist

A medicine for type 2 diabetes may slow the progression of the symptoms of Parkinson’s disease, research has suggested. Investigators evaluating the glucagon-like peptide 1 receptor agonist (GLP-1 RA) lixisenatide reported less progression of motor disability over a 12-month period in patients taking the drug compared with placebo. But writing in the New England Journal of Medicine, they […] The post Diabetes drug shows potential in treating Parkinson’s disease appeared first on The Pharma

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Seasonal variation of microbial contamination in pharmaceutical cleanrooms

European Pharmaceutical Review

Researchers investigating environmental microbial contamination found “no seasonal climatic influences were observed” in bacteria and fungi counts present in Grade D (ISO 8) Brazilian pharmaceutical cleanrooms. Samples were obtained via surface and air monitoring over a one-year period. While microbial levels were predicted to be higher during rainy periods compared to dry spells, “no statistically significant differences in bacteria and fungi counts were found between months or seasonal period

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Trial Findings for Minimally Invasive Parafascicular Technology Show Promise for Intracerebral Hemorrhage Treatment

Pharmaceutical Commerce

Results of the trial suggest that early intervention for intracerebral hemorrhage using parafascicular surgery were safe.

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Industry growth weakens sharply in Mar’24

Express Pharma

The India pharma market (IPM) grew 1.3 per cent YoY in Mar’24 (vs. 7.8 per cent in Feb’ 24 and 19.6 per cent in Mar’23). Growth was impacted by a sharp decline of 8 per cent/7 per cent in Respiratory/Anti-infective therapies. Cardiac/Derma/Neuro grew 8.2 per cent/6 per cent/5.8 per cent YoY in Mar’24. In 4QFY24, IPM grew by 5.7 per cent, higher by 220bp on YoY basis due to strong growth of 13.9 per cent/11.1 per cent in Urology/Cardiac therapies, offset by a decline of 2.9 per cent/2.2 per cent

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AstraZeneca study forecasts 16.5% population affected by chronic kidney disease by 2032

Outsourcing Pharma

AstraZeneca's latest modelling analysis, IMPACT CKD, presented at the 2024 ISN World Congress of Nephrology (WCN'24) in Buenos Aires, paints a concerning picture of the future of chronic kidney disease (CKD) across eight countries.

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Long-term data indicates “significant” potential of aGvHD microbiome treatment

European Pharmaceutical Review

Positive data from MaaT Pharma’s Microbiome Ecosystem Therapy TM (MET) MaaT013 as a treatment for acute graft-versus-host disease (aGvHD), is set to be presented at the 2024 European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting. Based on the long-term survival data, at 18 months MaaT013 enabled 42 percent overall survival in all patients and 58 percent in responder patients.

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Glenmark recalls 6,528 bottles of BP drug in US

Express Pharma

Glenmark Pharmaceuticals is recalling 6,528 bottles of Diltiazem Hydrochloride extended-release capsules, a medication used to treat high blood pressure in the American market due to failed dissolution specifications, informed USFDA in its latest Enforcement Report. The affected lot has been produced in India and is being recalled for “failed dissolution specifications”, the USFDA said. “Out of Specification (OOS) was reported in a test of dissolution at the 12th month time poi

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‘Broken’ medicine supply chain puts health at risk, AIMp and charities warn

The Pharmacist

The Association of Independent Multiple Pharmacies (AIMp) has joined with a group of charities to call for a complete review of the medicine supply chain. AIMp, along with Epilepsy Action, Epilepsy Society, Parkinson’s UK and SUDEP Action, has warned the government that unless there is ‘greater openness’ with drug manufacturers, supply chain issues and medicine […] The post ‘Broken’ medicine supply chain puts health at risk, AIMp and charities warn appeared first on The Pharmacist.

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