STAT

JANUARY 4, 2024

“I’m sorry, but I’m unable to take on new patients at this time.” I’ve said that line hundreds of times in the 15 years since I started my solo private practice in psychiatry. I feel terrible each time I say it. Someone on the other end of the phone is suffering and has taken the difficult step to call for help — probably multiple calls, given the longstanding shortage of psychiatrists — and yet I added to their hopelessness.

361

361

PharmaVoice

JANUARY 4, 2024

Key strategies for bringing more patients into the clinical trial fold.

264

264

STAT

JANUARY 4, 2024

The baby monitor didn’t go off. Any sound or motion in the twins’ room was supposed to set off an alarm — but in the wee hours of Nov. 27, 2022, Katie Czajkowski-Fell and Justin Fell weren’t woken up. They’d gotten it because of Hayden’s febrile seizures. These are common, generally nothing to worry about, the doctors said.

Immunity 345

Immunity Immunization 345

PharmaVoice

JANUARY 4, 2024

What can the industry expect in 2024? Some bright spots, a few bumps and “immaculate disinflation.

162

162

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.

STAT

JANUARY 4, 2024

Delfi Diagnostics, a startup devising new ways to use routine blood draws to detect early signs of cancer, told STAT Thursday that it has appointed Susan Tousi, chief commercial officer for genomics giant Illumina, as its new CEO. She is the fourth senior executive to leave Illumina since June. Tousi will start next week, just in time for the J.P. Morgan Healthcare Conference , while founding CEO Victor Velculescu will remain on the company’s board to help guide its research programs.

332

332

The Pharmacist

JANUARY 4, 2024

Two Reckitt infant formulas have been recalled over concerns that they are contaminated with the bacteria Cronobacter sakazakii. Batch ZL3F7D of Nutramigen LGG Stage 1 Hypoallergenic Formula 400g and batches ZL3FAA and ZL3FDM of Nutramigen LGG Stage 2 Hypoallergenic Formula 400g may have been contaminated with the bacteria, the Food Services Authority (FSA) has said. […] The post Infant formula recalled over contamination fears appeared first on The Pharmacist.

132

132

BioPharma Dive

JANUARY 4, 2024

Moonwalk Biosciences, the latest biotech cofounded by the gene editing scientist, joins other startups aiming to alter gene expression without changing DNA.

139

139

STAT

JANUARY 4, 2024

Allogene Therapeutics is making unexpected changes to development plans for its off-the-shelf cell therapy for a type of blood cancer — a concession that competition from personalized CAR-T treatments, already entrenched in the market, has become more challenging. In a strategic pivot, two clinical trials involving patients with later-stage lymphoma are being shut down.

308

308

pharmaphorum

JANUARY 4, 2024

Amplifying the patient voice is essential for the success of clinical trials. Learn why it is crucial for patient engagement, recruitment, and overall trial success, and how it can address challenges such as transportation and financial barriers.

129

129

STAT

JANUARY 4, 2024

Aera Therapeutics, a startup launched by the CRISPR pioneer Feng Zhang last year to solve one of the biggest bottlenecks in genetic medicine, has laid off a quarter of its staff, the company confirmed to STAT.  The layoffs come as the biotech market remains mired in a now nearly three-year-long downturn that has left startups struggling to attract both private and public funds.

308

308

Advertisement

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.

Pharmacy Management

BioPharma Dive

JANUARY 4, 2024

The company plans to restructure and will start a new late-stage study testing whether its “off-the-shelf” therapy can boost cure rates when used early on.

123

123

STAT

JANUARY 4, 2024

Between condoms and vasectomies lies a vast, undeveloped chasm of male birth control. Contraline, a device startup that released early, positive clinical data in a press release on Thursday, hopes to fill it. The company has built an injectable gel that’s inserted into the sperm duct, physically blocking the sperm from coming out. Investigators tested the device on 23 participants in Australia last year and recorded no serious adverse events.

301

301

The Pharmacist

JANUARY 4, 2024

MPs have written to pharmacy minister Dame Andrea Leadsom to raise concerns about the pressures facing community pharmacy. In a letter sent last month, they called for the government to urgently consider creating a new core funding model, and to focus on implementing and developing Pharmacy First, as well as other clinical service areas. These […] The post Cross-party MPs sound alarm over pharmacy pressures appeared first on The Pharmacist.

Community Pharmacies 112

Community Pharmacies 112

STAT

JANUARY 4, 2024

A new startup co-founded by CRISPR innovator Feng Zhang, a former executive at Grail and Illumina, and others has raised $57 million to develop a defanged form of gene editing that doesn’t cut the DNA strand. Moonwalk Therapeutics launched Thursday with funding from Alpha Wave Ventures, ARCH Venture Partners, Future Ventures, Khosla Ventures, GV, and YK Bioventures.

297

297

pharmaphorum

JANUARY 4, 2024

Scientists at Roche and Harvard University have discovered a new class of antibiotic that can kill carbapenem-resistant Acinetobacter baumannii (CRAB), a major public health threat

105

105

STAT

JANUARY 4, 2024

The J.P. Morgan Healthcare Conference is upon us, bringing its frenetic meetings, crowded hallways, and hotel rooms so expensive that even the pharmaceutical industry complains about what a free market does to the prices of scarce goods. This year’s iteration, starting Monday in San Francisco, finds the biotech industry, in particular, in a curious spot.

292

292

BioPharma Dive

JANUARY 4, 2024

The new program, dubbed LillyDirect, will help patients connect with telehealth providers and deliver medicines like the company’s obesity treatment Zepbound.

109

109

STAT

JANUARY 4, 2024

Novo Nordisk may already have one blockbuster obesity drug in its portfolio, but the Danish drugmaker has actively begun searching out others, including through a new partnership announced Thursday. Novo Nordisk will work with Omega Therapeutics, a startup founded by venture creation firm Flagship Pioneering, to develop a genetic editing treatment for obesity.

Pharmaceutical Companies 280

Pharmaceutical Companies Pharmaceutical Companies 280

PharmExec

JANUARY 4, 2024

Cretostimogene grenadenorepvec (CG0070) is currently being evaluated for the treatment of patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 tumors.

104

104

STAT

JANUARY 4, 2024

Several advocacy groups are blasting a Food and Drug Administration proposal to work with a Denver Health surveillance system for monitoring misuse of prescription opioids over long-standing ties the operation has to the pharmaceutical industry. At issue is the Research, Abuse, Diversion, and Addiction-Related Surveillance system, or RADARS, which was originally created as in-house monitoring program by Purdue Pharma and later sold to the Denver Health and Hospital Authority.

Hospitals 280

Hospitals 280

pharmaphorum

JANUARY 4, 2024

Digital health company Click Therapeutics has won an FDA breakthrough device designation for CT-155, a digital therapeutic (DTx) for the negative symptoms of schizophrenia, like social withdrawal and apathy, that tend not to respond well to antipsychotic drugs.

103

103

STAT

JANUARY 4, 2024

Rise and shine, everyone, another busy day is on the way. Sadly, gray skies are hovering over the Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will draw on a bit of insight from the Morning Mayor, who taught us that “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and invite you to join us.

Biosimilars 273

Biosimilars Diabetes 273

Pharma Times

JANUARY 4, 2024

Metastatic cancer is estimated to be responsible for 90% of cancer deaths

Hospitals 147

Hospitals Immunity Immunization 147

STAT

JANUARY 4, 2024

Health tech hopefuls might once have been used to a wealth of job options, especially in the pandemic’s early stages when investors pumped record-breaking dollar amounts into an unprecedented number of ventures. That glut of opportunities meant workers could bargain harder for better job offers, demanding perks and flexibilities like permanent remote work or expensive fertility benefits.

255

255

BioPharma Dive

JANUARY 4, 2024

The agency could soon clear important new drugs from Eli Lilly and Merck, as well as the first treatment for a common liver disease.

120

120

STAT

JANUARY 4, 2024

WASHINGTON — UCB left BIO at the end of 2023, the second major member company to exit after Pfizer pulled out as well. UCB, headquartered in Belgium, decided not to renew its BIO membership after a routine evaluation of its engagement in trade associations, said company spokesperson Erica Puntel. Pfizer, whose departure STAT reported first , was listed on BIO’s website as a sponsor at one of the group’s highest levels.

232

232

World Pharma News

JANUARY 4, 2024

Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, announced today the completion of the 18-month data collection in the Phase Ib clinical trial for AB-1005 (AAV2-GDNF), an investigational gene therapy for treating patients with Parkinson's disease (PD).

99

99

STAT

JANUARY 4, 2024

You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine.  Sign up here  to receive it in your inbox on Tuesdays and Thursdays. JPM in SF: STAT’s got you covered Next week, tens of thousands of people will descend on San Francisco’s Financial District for J.P.

Drug Pricing 215

Drug Pricing 215

Fusion Pharmacy

JANUARY 4, 2024

Serotonin I talk with a lot of patients who come through my pharmacy asking questions about their prescriptions and seeking advice about nutrition, amino acids, and hormone balancing. Given that we are in our winter months, I thought an article about a subject that is common this time of year would be appropriate. So, let’s talk about depression and serotonin.

98

98

STAT

JANUARY 4, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning, everyone. Damian here with an in-depth preview of a certain annual biotech conference, a look at the cutting edge of obesity drug development, and year’s first IPO filing.

Drug Development 172

Drug Development Drug Pricing 172

Express Pharma

JANUARY 4, 2024

The major depressive disorder (MDD) market is forecast to grow from $4.7 billion in 2019 to $9.6 billion by 2029 across the eight major markets (8MM*) at a compound annual growth rate (CAGR) of 7.4 per cent, according to GlobalData. GlobalData’s latest report, ‘Major Depressive Disorder: Eight-Market Drug Forecast and Market Analysis – Update, reveals that the main driver of growth will be recently approved drugs including Johnson & Johnson’s Spravato (esketamine) and Axsome Therapeutics’s A

Compounding 97

Compounding 97

Pharma Times

JANUARY 4, 2024

High amounts of disrupted sleep were found to affect memory and thinking performance

134

134

European Pharmaceutical Review

JANUARY 4, 2024

According to a paper recently published in the Biochemical Engineering Journal , challenges such as strict regulation and lack of industry awareness, limit the adoption of Industrial Internet of Things (IIoT) in bioprocessing and overall bioproduction. As a system that uses various technologies , such as data analytics and artificial intelligence (AI), to transfer data between each other autonomously in an industrial setting, IIoT “enables wide-scope data collection and utilisation, and reduces

97

97

pharmaphorum

JANUARY 4, 2024

Novo Nordisk has reaped the first harvest from its wide-ranging alliance with life sciences investor Flagship Pioneering, buying rights to two programmes from the VC’s portfolio companies Omega Therapeutics and Cellarity.

97

97

Express Pharma

JANUARY 4, 2024

ICRA expects the revenues of a sample set of 25 Indian pharma companies (which account for ~60 per cent of the overall revenues of the Indian pharma industry) to expand by 9-11 per cent in FY2024, post a YoY growth of 10 per cent in FY2023. The OPM for the sample set is projected to improve to 22-23 per cent in FY2024, against 20.7 per cent in FY2023, supported by new product launches backed by increased focus on complex generics/specialty molecules, easing of pricing pressure, and some benefits

89

89