STAT

JULY 23, 2024

Jeffrey Shuren, longtime chief regulator of medical devices at the Food and Drug Administration, announced to staff on Tuesday that he is leaving the agency, according to six sources and an email reviewed by STAT. Shuren, who spent 28 years at the agency, started his FDA career in the Commissioner’s Office in 1998. He became director of the Center for Devices and Radiological Health in 2009 and has served in that position ever since.

353

353

Pharmacy Is Right For Me

JULY 23, 2024

Hey there, future pharmacists! I’m Shelby, a student pharmacist at the University of Findlay (UF), and I’m here to share my journey with you. If you’re thinking about a career in pharmacy or just curious about what it’s like, you’re in the right place! Falling in Love with Findlay My adventure started the summer before my senior year of high school at Findlay’s Summer Pharmacy Camp.

Compounding 246

Compounding Hospitals 246

STAT

JULY 23, 2024

Hospitals across the country are facing a severe shortage of supplies of blood culture bottles, critical tools for diagnosing serious and sometimes life-threatening bloodstream infections. The Centers for Disease Control and Prevention sent out an alert Tuesday to health care providers, laboratory professionals, health care facility administrators, and state, tribal, local, and territorial health departments warning of the shortage of Bactec blood culture medium bottles, marketed by Becton Dicki

Hospitals 350

Hospitals 350

PharmaVoice

JULY 23, 2024

BARDA director Gary Disbrow explains the agency’s focus, how companies can get their “foot in the door” and why platforms are so important for preparedness.

130

130

Speaker: Joe Sharpe and James Carlson

In the world of small business management, the challenge of managing payroll & HR efficiently while scaling operations can be overwhelming. Yet, with the right strategies in place, these challenges can become opportunities for growth and innovation. In this session, Joe Sharpe, Senior Director of Managed Payroll Services at IRIS, will reveal practical methods and expert insights for outsourcing and streamlining payroll processes, resulting in substantial time and resource savings.

STAT

JULY 23, 2024

Medicare and Medicaid are facing a familiar quandary: how to provide coverage for new weight loss drugs with price tags that could effectively bankrupt the federal government’s health care budget while simultaneously ensuring continuous coverage for all other health care services used by millions of Americans. The Centers for Medicare and Medicaid Services announced in March 2024 that it would cover Wegovy (semaglutide), a new and expensive weight loss medication, for beneficiaries with c

Drug Pricing 348

Drug Pricing 348

PharmaVoice

JULY 23, 2024

Private biotech company acquisitions are on their fastest pace in years, a trend some in the industry say is driven by the abundance of mature, but not yet public, drug startups.

100

100

The Pharmacist

JULY 23, 2024

Primary care network (PCN) pharmacists should be enabled to prioritise structured medication reviews (SMRs) in the highest risk patients, the Royal Pharmaceutical Society (RPS) has said in a policy statement today. This follows concerns that PCNs and practices are deprioritising SMRs and directing pharmacists towards other work. RPS England vice-chair Brendon Jiang suggested that the […] The post Pharmacists must be enabled to prioritise SMRs, urges RPS appeared first on The Pharmacist.

125

125

STAT

JULY 23, 2024

Following the release of widely touted study results for a Gilead Sciences HIV treatment, a new analysis finds the medicine — called lenacapavir — could be made for as little as $26 to $40 per person each year, which the researchers argue could alleviate concerns about limited access in many countries. The medicine drew considerable attention last month after a late-stage clinical trial found that twice-a-year injections completely protected cisgender women from contracting HIV.

336

336

The Pharmacist

JULY 23, 2024

Primary care networks (PCNs) are employing 37,000 staff through the additional roles reimbursement scheme (ARRS), including pharmacists, social prescribers and physician associates, according to NHS England. A spokesperson told our sister title Pulse PCN that as of June, there were ‘37,000 roles under the programme currently in place’, which is 43% higher than their original […] The post ARRS hits a high of 37,000 staff, NHS confirms appeared first on The Pharmacist.

117

117

STAT

JULY 23, 2024

CVS Caremark, one of the largest pharmacy benefit managers in the country, agreed to pay at least $45 million to the state of Illinois to settle allegations that rebates were not passed through during a recent four-year period, according to a document obtained by STAT. At issue is a complicated, behind-the-scenes relationship between the PBM and several related entities — in particular, a so-called group purchasing organization — that allegedly obscured rebates paid by drug manufac

Documentation 331

Documentation 331

Advertisement

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

The Guardian - Pharmaceutical Industry

JULY 23, 2024

Generic version of a drug already on the market, which can suppress and prevent HIV, would still yield 30% profit if the current price was slashed, researchers say A new drug described as “the closest we have ever been to an HIV vaccine” could cost $40 (£31) a year for every patient, a thousand times less than its current price, new research suggests.

Vaccines 111

Vaccines 111

STAT

JULY 23, 2024

The House Oversight Committee kept pressure on drug middlemen at a hearing today that focused on a new committee report that criticizes industry practices. Pharmacy benefit managers steer patients to PBM-owned pharmacies while underpaying competing pharmacies, according to the report, which highlights concerns that lawmakers have been pounding for years.

Packaging 304

Packaging Drug Pricing 304

FDA Law Blog: Biosimilars

JULY 23, 2024

By Adrienne R. Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. EPRs were usually requested in the context of design controls, although 21 C.F.R. § 820.30 does not use this term.

Labelling 105

Labelling 105

STAT

JULY 23, 2024

WASHINGTON — The Biden administration’s proposal to loosen federal restrictions on marijuana is dividing some of the nation’s top medical professionals. The nation’s largest and most powerful doctors group, the American Medical Association, has raised multiple concerns with the move, which is known as rescheduling. The American Psychiatric Association has said the drug should remain a Schedule I substance, like heroin and cocaine, one deemed to have no proven medical

302

302

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.

pharmaphorum

JULY 23, 2024

Agilent has boosted its contract development and manufacturing organisation (CDMO) capacity with a $925 million deal to buy Biovectra, a Canadian provider of fill-and-finish services and active pharmaceutical ingredients (APIs).It's a statement of intent from Agilent, whose primary business is lab instrumentation and equipment, suggesting that it intends to grow the outsourcing side of its business, which is currently focused on the production of oligonucleotide and peptide medicines.

105

105

STAT

JULY 23, 2024

When Sanjaya Singh left Johnson & Johnson in 2021, his former colleague Peter Lebowitz paid close attention. Singh had been a mainstay in the immunology and oncology fields, helping to invent the blockbuster drug Skyrizi and several other treatments during stints at Johnson & Johnson and Boehringer Ingelheim. “If Sanjaya Singh is doing something, you want to watch it,” Lebowitz said.

294

294

pharmaphorum

JULY 23, 2024

Former Welsh rugby union captain Alum Wyn Jones is the face of a new awareness campaign launching in the UK today to draw attention to atrial fibrillation (AF), an irregular and potentially life-threatening heart rhythm abnormality.

101

101

STAT

JULY 23, 2024

The Food and Drug Administration designates as “breakthrough” technologies certain drugs and devices. This designation helps expedite the development and review of therapies intended to treat serious conditions that may offer improvements over available therapies. Once breakthrough drugs and devices are approved, however, devices face a far less predictable pathway and a longer timeline to achieving reimbursement, including coverage by payers such as Medicare, compared to breakthro

266

266

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

The Pharmacist

JULY 23, 2024

Pharmacist partners in general practice are being asked whether they would support potential 'collective action' by GPs in the coming weeks. GP partners could soon be taking action - such as limiting daily patient contacts and switching off various software - if a non-statutory ballot, being held by the British Medical Association (BMA), is successful. […] The post Pharmacist practice partners asked for views on GP 'collective action' appeared first on The Pharmacist.

101

101

STAT

JULY 23, 2024

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences.  Sign up to get it  delivered in your inbox every Tuesday and Thursday. Wastewater surveillance program sheds testing sites Sewage analysis has been in the spotlight recently as experts warn of an ongoing summer Covid surge.

Mayo Clinic 261

Mayo Clinic 261

The Pharmacist

JULY 23, 2024

Almost all staff working in general practice report having been verbally abused, with the issue worsening, a survey has found. Nearly half of respondents also said they had experienced physical violence or threats to hurt them in the past three years. The results presented at the Society for Academic Primary Care’s annual conference show that violence and […] The post Almost all general practice staff have been verbally abused, study finds appeared first on The Pharmacist.

101

101

STAT

JULY 23, 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. In an unfortunate twist of fate, an Oscar Mayer Weinermobile crashed into another vehicle and flipped on its side yesterday while driving around Chicago, famously known for its hot dogs. Thankfully, no injuries were reported.

Drug Pricing 252

Drug Pricing Drug Development 252

pharmaphorum

JULY 23, 2024

GSK has challenged Gilead's HIV behemoth Biktarvy, presenting data that its competing therapy Dovato is equally effective and associated with less weight gain.

97

97

STAT

JULY 23, 2024

Veterans Affairs department officials said Monday they have launched a study to determine how removing race from widely used lung function tests may affect disability benefits for veterans, and they expect the impact to be much smaller than predicted in a study published earlier this year. They also said veterans who may have heard about the issue should not be concerned about any sudden changes to their benefits.

239

239

Express Pharma

JULY 23, 2024

Gland Pharma a generic injectable-focused pharmaceutical company, has received tentative approval from the United States Food and Drug Administration (USFDA) for Latanoprostene Bunod Ophthalmic Solution, 0.024 per cent. The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vyzulta Ophthalmic Solution, 0.024 per cent, registered by Bausch & Lomb.

Pharmaceutical Companies 92

Pharmaceutical Companies Pharmaceutical Companies 92

pharmaphorum

JULY 23, 2024

Irina Spirieva, from Besins Healthcare, answers 12 intriguing questions about her journey in the healthcare industry. Learn more about her experiences and insights.

95

95

Express Pharma

JULY 23, 2024

BioCity Biopharma recently announced positive results from the ongoing 2-SUCCEED trial. The use of SC0062 resulted in a clinically meaningful and statistically significant reduction in proteinuria in patients with immunoglobulin A (IgA) nephropathy (IgAN). The ageing global population will lead to an increase in the prevalence of chronic kidney disease (CKD), leading to an expansion of the market as well as a growing need for more therapeutic options.

Immunity 92

Immunity Immunization 92

Pharmaceutical Technology

JULY 23, 2024

Johnson & Johnson is seeking approval for SPRAVATO for treatment-resistant depression with the submission of an sNDA to the US FDA.

101

101

Express Pharma

JULY 23, 2024

ZIM Laboratories is a research-driven pharmaceutical company which develops, manufactures and supplies differentiated generic products in oral solid dosage forms, across key therapeutic segments. The company has in-house R&D capabilities to offer innovative drug delivery solutions using proprietary technology platforms with the aim of providing patient convenience and treatment adherence.

Dosage 90

Dosage Pharmaceutical Companies Pharmaceutical Companies 90

Pharma Times

JULY 23, 2024

The life-threatening medical condition affects 100,000 people in the UK every year

118

118

Express Pharma

JULY 23, 2024

“The Union Budget 2024-25, presented by FM Nirmala Sitharaman, marks a significant milestone as the first budget of the re-elected BJP-led NDA government. We at OPPI commend the government’s commitment to improving healthcare access and innovation in India, reflecting a forward-looking approach that aligns with our industry’s aspirations. We deeply appreciate the government’s decision to exempt three critical cancer medicines – Trastuzumab Deruxtecan, Osimertinib, and Durvalumab – fr

Pharmaceutical Companies 90

Pharmaceutical Companies Pharmaceutical Companies 90

pharmaphorum

JULY 23, 2024

Ionis plans phase 3 trial of its antisense therapy for Angelman syndrome, shortly after Biogen decided against exercising an option to license the drug

88

88

Express Pharma

JULY 23, 2024

Nirmala Sitharaman presented the Union Budget for 2024-25 for a record seventh time today. PM Narendra Modi said that his term’s first full Union Budget will lay the foundations of ‘Viksit Bharat’ and economic trends for Modi 3.0. Some key highlights in this budget for pharma are: Three more medicines viz. Trastuzumab deruxtecan, Osimertinib, and Durvalumab have been exempted from Customs Duties.

89

89