March, 2023

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Opinion: To deal with the next pandemic, the FDA needs an Office of Preparedness and Response

STAT

New evidence of the spillover of the avian flu virus, known as H5N1, to some mammals is again raising alarm bells, though for experts familiar with the virus, “ none of them ever stopped worrying about H5N1.” The recent death of a Cambodian girl from bird flu is a reminder that much is at stake. If H5N1 were to cross over to humans and ignite another pandemic, could the United States do it all over again?

Vaccines 364
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The Febrile Infant: Incorporating the 2021 American Academy of Pediatrics guidelines

ALiEM - Pharm Pearls

Can you trust a febrile infant? “No” has been, and continues to be, the resounding answer over the last 40 years as researchers and clinicians work to determine the optimal evaluation and management of the well-appearing young febrile infant [1]. The goal remains to identify infants with bacterial infections in this at-risk cohort of patients while also considering the balance of cost-effectiveness on a population scale and the potential for iatrogenic harm with evaluation such as unnecessary lu

Hospitals 360
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SCOTUS to decide ‘fundamental change’ in biologics patents with fate of Amgen v. Sanofi

PharmaVoice

The Supreme Court will now decide whether Amgen can protect Repatha as a whole class of drugs or whether Sanofi’s rival product Praluent can retain a place in the market.

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First nasal monoclonal antibody COVID-19 treatment shows potential

European Pharmaceutical Review

A pilot study has demonstrated that a nasal version of the drug Foralumab, an anti-CD3 monoclonal antibody suppressed the inflammatory T cell response and decreased lung inflammation in patients with COVID-19. “This is the first nasal monoclonal antibody—other monoclonal antibody treatments were delivered intravenously and are no longer given as treatment because they are not effective against currently circulating viral variants,” explained Dr Howard Weiner, founder and Director of the Brigham

Immunity 145
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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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PulmCrit Hot Take: Steroid for severe pneumonia (CAPE COD trial)

EMCrit Project

Steroid is worthless for pneumonia! Wait, a new study shows it's beneficial! Hang on, a fresh meta-analysis shows that steroid it's useless! And wait, here's a fresh NEJM study showing mortality benefit!! This feels like a roller coaster. What's going on here? Several factors may explain this: Steroid is beneficial, but only in a subset […] EMCrit Project by Josh Farkas.

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Mathai Mammen, former J&J executive, to become FogPharma CEO

BioPharma Dive

The veteran pharmaceutical executive was J&J’s head of R&D until his departure last August. He’s agreed to run FogPharma, a richly funded startup, and take over for founder Greg Verdine.

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11 Tips to Improve Epistaxis Management in the Emergency Department

ALiEM - Pharm Pearls

Managing epistaxis is often challenging, time-consuming, and takes practice. Even under the best circumstances, epistaxis often results in return visits for rebleeding and poor outcomes. Rarely should you do “nothing” for adults who present to the ED with or following epistaxis. If it produced enough blood to seek care (even without hemodynamic compromise), epistaxis frequently recurs even if currently resolved.

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Viral roots: A look at how modern outbreaks began

PharmaVoice

As experts wrestle with COVID-19’s lab leak versus animal market debate, here’s what experts say are the suspected origins for some of the worst viral outbreaks in the last century.

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Identifying origin of fungi in cleanrooms

European Pharmaceutical Review

In a recent video , pharmaceutical microbiology expert Tim Sandle highlighted areas of concern and attention relating to mycological contamination control in manufacturing. Pharmaceutical product recalls due to fungal contamination have been increasing. These, together with environmental monitoring trend data, highlight several fungal contamination issues associated with pharmaceutical cleanrooms , cold rooms and other controlled areas.

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Three in four pharmacies experiencing a pharmacist shortage, MPs told

The Pharmacist

Almost three-quarters of pharmacies are experiencing a shortage of pharmacists, members of parliament were told at a roundtable event this week. MPs from across the political spectrum attended the event at parliament on Tuesday hosted by cross-sector campaign group Save Our Pharmacies. Community pharmacy leaders set out the challenges facing the sector, including early results […] The post Three in four pharmacies experiencing a pharmacist shortage, MPs told appeared first on The Pharmacis

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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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ALS drugmakers, encouraged by recent FDA feedback, set their sights on a key protein

BioPharma Dive

A closely watched meeting showed the FDA’s own external advisers think that effects on this protein, known as neurofilament, could be enough to warrant conditional approval of certain drugs.

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Opinion: I finally got used to practicing telepsychiatry. Now the DEA wants to change everything

STAT

I am by no means telepsychiatry’s biggest fan. But since March 2020, when my practice of outpatient psychiatry changed overnight, I have adapted to it. I have learned to get up between appointments so I don’t sit in front of a computer all day and how to fit in patient visits while on a work trip. I still prefer being in the actual room with a patient, but I accept this is the way my job looks now.

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Why Congress should prioritize fixing the 340B program

PhRMA

Nearly all Americans nationwide agree: Lowering out-of-pocket costs for health care should be a top priority for policymakers. Luckily, there are commonsense policies Congress could implement to meaningfully address the cost burdens Americans face. These include things like making sure patients aren’t paying more for their medicines than their health insurance company or requiring first-dollar coverage, so insurance companies cover the cost of certain lifesaving medicines from day one of the pla

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‘The Last of Us’ might be fiction, but fungi are a looming threat

PharmaVoice

Fungal infections are a growing challenge for hospitalized patients, and new treatments are badly needed.

Hospitals 306
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New NHS cell and gene therapy centre opens

European Pharmaceutical Review

Today marks the opening the NHS Blood and Transplant (NHSBT)’s new Clinical Biotechnology Centre (CBC) in Bristol. The state-of-the-art facility was part-funded by a £9.43 million Government grant and is designed to expand the UK’s ability to manufacture new gene and cell therapies. The CBC will help the UK grow its cell and gene therapy industry in a rapidly growing international market.” “The CBC will help the UK grow its cell and gene therapy industry in a rapidly growing international

Vaccines 137
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InvisiShield and Gladstone partner to develop intranasal preventatives

Pharmaceutical Technology

Pre-clinical-stage biotechnology firm InvisiShield Technologies has partnered with Gladstone Institutes to develop intranasal preventatives against airborne viral infections including influenza, respiratory syncytial virus (RSV) and SARS-CoV-2. Under the partnership terms, InvisiShield will offer technical support, as well as funding to develop the intranasal preventatives.

Immunity 115
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BrainStorm files ALS drug application over FDA protest

BioPharma Dive

The medicine, a personalized stem cell treatment, will be reviewed by an FDA advisory committee sometime in the future, the company said.

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Denied by AI: How Medicare Advantage plans use algorithms to cut off care for seniors in need

STAT

An algorithm, not a doctor, predicted a rapid recovery for Frances Walter, an 85-year-old Wisconsin woman with a shattered left shoulder and an allergy to pain medicine. In 16.6 days, it estimated, she would be ready to leave her nursing home. On the 17th day, her Medicare Advantage insurer, Security Health Plan, followed the algorithm and cut off payment for her care, concluding she was ready to return to the apartment where she lived alone.

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IRA Impacts: Cancer treatment research and development

PhRMA

Last month marked the one-year anniversary of the reignited Cancer Moonshot, the White House’s ambitious goal of reducing the death rate from cancer by at least 50% over the next 25 years. Much of the positive trends in declining cancer mortality, down 33% since peaking in 1991, is driven in large part by innovative medicines researched and developed by America’s biopharmaceutical companies.

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Janssen neuroscience leader takes on rare diseases one small ‘eureka’ at a time

PharmaVoice

Fueled by a fascination with the scientific process, Sindhu Ramchandren is exploring how a new drug could treat patients with a range of rare diseases.

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Pfizer to acquire Seagen for $43 billion

European Pharmaceutical Review

Pfizer has announced it will acquire Seagen Inc. for a total enterprise value of $43 billion. “Together, Pfizer and Seagen seek to accelerate the next generation of cancer breakthroughs and bring new solutions to patients by combining Seagen’s antibody -drug conjugate (ADC) technology… with Pfizer’s capabilities and expertise,” shared Dr Albert Bourla, Pfizer Chairman and Chief Executive Officer.

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Brazil’s ANVISA approves Takeda’s dengue vaccine candidate Qdenga

Pharmaceutical Technology

The National Health Surveillance Agency (ANVISA) in Brazil has granted approval for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003). The vaccine has received approval for preventing dengue disease in people aged four years to 60 years. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes and is designed to provide protection against any of these.

Vaccines 114
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CMS removes 7 drugs from list marked for price hike penalties

BioPharma Dive

After revising its calculations, CMS removed Gilead’s cancer cell therapies Yescarta and Tecartus, as well as 5 other medicines, from the first set of drugs subject to rebates under a provision of the IRA.

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STAT+: SVB, biotech’s bank of choice, just failed. It could have ripple effects

STAT

Silicon Valley Bank, which does business with roughly half of the nation’s tech and biotech companies, failed on Friday. Now, as federal regulators step in to clean up SVB’s mess, biotech startups are left wondering: What happens to their money, and who’s going to finance the industry? On Friday morning, the Federal Deposit Insurance Corporation took control of SVB and is presiding over a sale of the firm’s assets to cover clients’ deposits.

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Key Trends: Patient experience data reveal how insurers and middlemen impose barriers in health care

PhRMA

The Patient Experience Survey (PES) series continues to reveal how health insurance is not working as it should for too many Americans — especially vulnerable groups. This series – including surveys of 5,000 Americans conducted with Ipsos, a leading research company in the United States — documents a consistent trend in reports of insurer- and middlemen-imposed practices that can keep patients from the medicines and treatments that they need.

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A rising oncology powerhouse in China, BeiGene looks to strengthen its international punch

PharmaVoice

To expand its reach, Christiane Langer, the company’s head of medical affairs, is leaning on connections and singularity over fitting in a box.

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Trends in pharma packaging

Express Pharma

Pharmaceutical packaging has come a long way in recent years. The industry constantly innovates to provide the most reliable and efficient packaging solutions, from automated assembly lines to shrink-wrap and other state-of-the-art technologies. The rise of new drug delivery systems, such as inhalers and patches, has changed how drugs are packaged and presented to consumers.

Packaging 111
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Rapid microbiology testing market growth expected 2022 to 2027

European Pharmaceutical Review

A report has predicted the rapid microbiology testing market size is estimated to grow at a compound annual growth rate (CAGR) of 9.31 percent between 2022 and 2027. According to the data, the market is forecasted to increase by $2,487.91 million. The research includes historic market data from 2017 to 2021, using 2022 as the base year. It covers various testing methods such as growth-based, nucleic-acid-based and viability-based.

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At EpiBiologics, a pair of Genentech alumni wants to make next-gen protein degraders

BioPharma Dive

Armed with a $50 million Series A round, the startup is building off of research from a lab run by protein engineering pioneer Jim Wells.

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Opinion: How physician wellness programs keep doctors captive

STAT

The American College of Surgeons recently announced its new well-being initiative for surgeons. This wellness program has lofty goals: [The ACS] recognizes the need to foster well-being, resilience, and work-life integration for all surgeons, regardless of their career stage. Fostering the growth of both the surgical expertise and the person as a whole is paramount.

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Hipra’s Covid-19 booster gets EMA nod and enters an uncertain landscape

Pharmaceutical Technology

The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March. Bimervax is a recombinant protein subunit vaccine, marketed by the Girona, Spain-based Hipra.

Vaccines 110
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Woman of the Week: Psilera’s Jackie von Salm

PharmaVoice

Psilera founder’s “third eye” approach to psychedelics ushers them into the therapeutic realm.

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China approves its first mRNA vaccine from CSPC

Express Pharma

China has approved its first domestically developed mRNA vaccine against COVID-19, CSPC Pharmaceutical Group said. China, whose home-grown vaccines are seen as less effective than the Moderna and Pfizer-BioNTech mRNA shots, has been racing to develop vaccines using messenger RNA (mRNA) technology since early 2020. The long-awaited approval comes as infections have fallen sharply across China since it suddenly dropped its strict “zero-COVID” curbs in December, making the sales outlook

Vaccines 111
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GOSH and Leucid to manufacture novel CAR T therapy

European Pharmaceutical Review

In a first-of-its-kind commercial agreement, Great Ormond Street Hospital NHS Foundation Trust (GOSH) will work with Leucid Bio to manufacture LEU011, a lateral Chimeric Antigen Receptor (CAR) targeting NKG2D ligands. The CAR T therapy will be used in clinical studies for solid tumours and haematological malignancies. Under the agreement the parties will work together at state-of-the-art cleanroom facilities at the Zayed Centre for Research into Rare Disease in Children.

Immunity 113
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Biotech startups face ‘Series A cliff’ as venture capital stays cautious

BioPharma Dive

Series A rounds have been easy to secure in the last few years, but industry watchers say they haven't seen a corresponding increase in Series B's as startups struggle to recruit new investors.

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