Sat.May 06, 2023 - Fri.May 12, 2023

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Reports patients trying to access Pharmacy First early

The Pharmacist

Community pharmacies have had to turn patients away who thought that new pharmacy services announced this week were already available, leaders in the sector have told. On Tuesday, NHS England announced that a nationally funded Pharmacy First service will be launched in England before the end of 2023, subject to consultation. National newspaper headlines heralded […] The post Reports patients trying to access Pharmacy First early appeared first on The Pharmacist.

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Insulin prices have dropped — will Civica still be a disrupter in the field?

PharmaVoice

The nonprofit generics maker still sees a need for low-cost insulin despite recent moves by major drugmakers to slash the prices of their popular products.

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FDA panel votes in favor of the first-ever over-the-counter birth control pill

STAT

In a highly significant move, a panel of independent experts on Wednesday voted unanimously that the Food and Drug Administration should approve the first over-the-counter birth control bill, a recommendation that holds the potential to transform the way contraception is delivered in the United States. After nearly two days of deliberations, the FDA advisory panel weighed a gamut of data and analyses to assess whether the pill — which was first approved as a prescription medicine decades

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BioNTech’s RNA vaccine sparks potential in pancreatic cancer

Pharmaceutical Technology

Results published in Nature for a personalised pancreatic cancer vaccine that uses neoantigens from patients’ tumours have lent further support to early positive signals. The vaccine, developed by BioNTech, led to half of the patients with pancreatic cancer in the Phase I trial remaining cancer-free 18 months later. In the study, 16 patients were treated with a vaccine called autogene cevumeran that contained a maximum of 20 neoantigens, alongside Roche’s anti-PD-L1 immunotherapy Tecentriq (atez

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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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FDA panel narrowly backs approval of Sarepta’s Duchenne gene therapy

BioPharma Dive

Advisers voted 8-6 in favor of an accelerated approval despite uncertainty around the treatment’s benefit. The agency is set to make a final decision by May 29.

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This ‘hot-blooded’ CEO is aiming to transform the way burn victims heal

PharmaVoice

Cutiss CEO Daniela Marino is funneling her bold personality and expertise in regenerative medicine into a startup developing bioengineered skin grafts.

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The emergence of tranq amidst the fentanyl crisis

Pharmaceutical Technology

In February, the FDA issued an alert restricting the import of the veterinary sedative xylazine or tranq and the ingredients used to make the drug. This followed in the wake of a Drug Enforcement Agency (DEA) Joint Intelligence Report in October 2022, which stated that xylazine is widely available from Chinese suppliers on the internet. According to a June 2022 study, xylazine has been detected in the illicit drug supply in 36 US States, and the DEA has reported that approximately 30% of the f

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Cancer vaccine from BioNTech, Roche shows potential in small study

BioPharma Dive

The companies’ personalized shot generated tumor-specific T cells that researchers hope could help prevent pancreatic cancer from returning after surgery.

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How pharma’s rocky real estate market has changed — for better and worse

PharmaVoice

Whether you’re looking to build a new site or expand lab space, here are the biggest trends impacting life sciences real estate.

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From fusion to retooling cancer trials, Eric Lander wants his new group to ‘go after big problems’

STAT

Throughout his storied career , Eric Lander has led science projects in just about every setting there is: academia at MIT and Harvard Medical School, independent nonprofit research institutions like the Whitehead and the Broad institutes, startups, think tanks, international consortia, and the federal government. But President Biden’s former science adviser and longtime leader of the Broad never found a space totally free of the constraints of doing science in America.

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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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Episode 816: Delayed Sequence Intubation With Ketamine RCT Results

Pharmacy Joe

In this episode, I’ll discuss a randomized controlled trial about delayed sequence intubation. Episode 816: Delayed Sequence Intubation With Ketamine RCT Results Subscribe on iTunes , Android , or Stitcher In a typical rapid sequence intubation, there is a period of time referred to as “pre-oxygenation” where the patient needs to breath 100% oxygen for 3 minutes in order to extend the safe apnea time and maximize the chance of successful intubation without hypoxic injury.

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FDA staff skeptical of Sarepta’s Duchenne gene therapy, documents show

BioPharma Dive

Sarepta has not provided “unambiguous evidence” its treatment can help patients, agency scientists wrote in documents released ahead of a crucial Friday advisory committee meeting.

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AbbVie’s Christopher Boone on RWE’s potential — and its ‘profound ethical dilemmas’

PharmaVoice

With decades of experience in public health, Boone is leveraging RWE to move the needle within clinical development.

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STAT+: EQRx abandons business plan around drug pricing, cuts jobs and programs

STAT

EQRx, a company that aimed to lower drug prices by introducing inexpensive me-too medicines, said Tuesday that it has abandoned that plan and is laying off nearly 60% of its workforce. The company’s original business plan was to create new medicines in the same categories as high-priced cancer and specialty drugs and to sell them at lower prices through a “global buyers club” that included insurers and hospitals.

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Should Pharmacy School Admissions Hold Off on the PCAT Retirement Party?

Pulses

By: Esther L. Albuquerque, Pharm D Candidate and W. Renee’ Acosta, R.Ph., M.S. The Pharmacy College Admissions Test (PCAT) has been a mainstay of the pharmacy school admissions process since 1974. The exam was designed to measure a prospective student’s academic preparedness for the rigors of the professional pharmacy curriculum. With the COVID-19 pandemic in 2020 being a barrier to pharmacy school application numbers, the PCAT was one of the first requirements that moved to optional status.

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Alzheimer’s doctors see promise, limits in Lilly’s latest drug data

BioPharma Dive

While some see the new donanemab results as adding to a “watershed moment” in Alzheimer’s research, others say they reinforce the limitations of so-called anti-amyloid therapies.

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Led by the Pfizer-Seagen deal, ADCs are starting to ‘take center stage’

PharmaVoice

Antibody-drug conjugates got a major boost with the megamerger of Pfizer and Seagen, and experts believe they will continue to be an important catalyst in biopharma.

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Rare-disease doctors support expanded newborn genomic screening, survey finds

STAT

Plummeting costs of DNA sequencing technologies are injecting urgency into the longstanding debate over whether to dive deeper into the genomes of more infants — even apparently healthy ones. Experts are divided about how helpful DNA sequencing data really are. The tests often identify mutations that raise someone’s risk of developing a condition, but don’t necessarily cause the disease.

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Gilead wins patent battle with US government over HIV PrEP drugs

Pharmaceutical Technology

Gilead Sciences has emerged victorious in a legal battle with the US government over patents surrounding the HIV pre-exposure prophylaxis (PrEP) drugs Descovy and Truvada following a federal jury’s verdict on May 9. A jury in the Delaware District Court gave a favourable verdict to the Foster City, California-headquartered company, concluding that Gilead did not infringe any of the US government’s patents.

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‘The luckiest of the unlucky’: A Duchenne gene therapy brings hope to families — and tests the FDA

BioPharma Dive

Patient advocates and doctors are anticipating an approval this month of a treatment they believe to be a breakthrough for a deadly disease. But it’s not clear how well the therapy really works, putting the FDA in a difficult position.

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3 key FDA approval trends this year

PharmaVoice

Although approvals are off to a slow start in oncology, the agency has been living in the fast lane for neurological disorders and more.

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Opinion: The amoxicillin shortage continues to force pediatricians and families to scramble

STAT

“S o, you don’t have it in liquid form?” I asked. The answer, as usual, was no. I hung up the phone and sighed.

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Synlogic’s SYNB1934 receives orphan drug status from US FDA

Pharmaceutical Technology

Synlogic has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for SYNB1934 to treat phenylketonuria (PKU), a rare inherited metabolic disease. The orally administered, non-systemically absorbed drug candidate SYNB1934 has been designed for reducing blood phenylalanine (Phe) levels in PKU patients. SYNB1934 consumes Phe in the gastrointestinal (GI) tract by leveraging genetic engineering of the drug or drug-carrying capsule, probiotic escherichia coli (E coli)

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Gilead acquires San Diego startup for early-stage cancer, immune drugs

BioPharma Dive

The buyout of privately held XinThera continues a string of recent acquisitions of smaller biotechs by Gilead and hands it a group of drug prospects that could begin clinical testing later this year.

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Woman of the Week: Reneo Pharmaceuticals’ Ashley Hall

PharmaVoice

After ushering a blockbuster to market, the chief development officer is channeling her experience into the rare disease space.

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STAT+: How the FDA’s pandemic flexibilities boosted mental health apps — and what happens now

STAT

In April 2020, the Food and Drug Administration announced a pandemic enforcement policy allowing mental health app developers to release certain treatment products without seeking authorization from the agency. With the end of the official public health emergency, companies that did so will now need to submit the products for FDA clearance and have them pass an early stage of review by early November — or remove the products from the market.

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Ginkgo and Boehringer partner to develop hard-to-treat disease therapies

Pharmaceutical Technology

Ginkgo Bioworks and Boehringer Ingelheim have collaborated to develop breakthrough therapies for hard-to-treat diseases. The companies will use the natural product discovery capabilities of Ginkgo Bioworks to expedite the discovery and development of new therapeutic molecules to address diseases with high unmet patient needs. They will also use the metagenomic sequence database of Ginkgo Bioworks which comprises more than three terabases of sequence data and over two billion protein sequences fr

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EQRx resets strategy, abandoning plans to disrupt drug pricing

BioPharma Dive

Launched in 2020 with a "radical" vision, EQRx ran into roadblocks that stymied its efforts to develop new medicines and undercut competitors on price.

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Can GLP-1 obesity therapy restore NK cell function?

European Pharmaceutical Review

NK cell functionality was restored in participants following gold-standard pharmacological obesity GLP-1 analogue treatment, according to a study published in Obesity. This may contribute to the benefits reported with these medications in people with obesity, the data showed. Reducing the risk of cancer in obese individuals Boosting function of NK cells Previous research has found that people with obesity are at higher risk for developing cancer.

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STAT+: Senate panel passes a suite of drug pricing bills — but fails to advance one major PBM reform

STAT

WASHINGTON – The Senate health committee on Thursday passed a package of bills aimed at speeding generic drug competition and reining in drug middlemen business practices. But they failed to pass an ambitious reform to the pharmacy benefit manager sector, despite strong bipartisan support for it. Chairman Bernie Sanders (I-Vt.) is pursuing the drug pricing reforms at the behest of Senate Majority Leader Chuck Schumer (D-N.Y.), who wants to hold a floor vote on an even bigger package of he

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Celebrating our achievements at the Antibiotic Guardian Awards 2023

Commonwealth Pharmacists Association

Celebrating our achievements at the Antibiotic Guardian Awards 2023 The sixth Antibiotic Guardian Shared Learning and Awards event took place on the 2nd of May 2023 in London [link] The Antibiotic Guardian Awards is an initiative by the UK Health Security Agency (UKHSA) to recognise individuals and organisations that have made outstanding contributions to promote the […]

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Recursion to acquire two Canadian drug discovery startups

BioPharma Dive

The company agreed to buy Cyclica and Valence after winnowing down a list of more than 100 potential takeover targets, its CEO told BioPharma Dive.

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Researchers develop CRISPR-based drug candidate for microbiome targeting

Pharmaceutical Technology

The Technical University of Denmark (DTU) has announced that an international scientific team has developed a CRISPR-based drug candidate that targets E coli directly and leaves the microbiome intact. Blood cancer patients with E coli infection are at risk of bacteria infecting the bloodstream. An E coli infection can be fatal in these cases, with a 15-20% mortality rate.

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An ultrasound device may unlock brain cancer treatment, early study shows

STAT

Brain cancer patients are left with few options when tumor cells spread, as most potent chemotherapies are unable to cross the blood-brain barrier. But a study published last week in the Lancet offers some hope: an ultrasound device implanted in 17 patients’ skulls successfully increased the concentration of drugs in their brains.  It’s the first, in-human trial of the novel device, which is manufactured by French device maker Carthera.

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Glenmark Foundation concludes fifth season of ‘Meri Poushtik Rasoi’ National Cooking Contest

Express Pharma

Glenmark Foundation, in collaboration with Idobro Impact Solutions, announced the successful conclusion of the fifth season of the “Meri Poushtik Rasoi” cooking contest. As a pan-India initiative, it aimed at addressing the issue of malnutrition through the promotion of nutrition-rich native recipes, which could be used to tackle this issue at local, grassroots levels, both in urban and rural areas of the country.