STAT

JULY 11, 2023

Takeda announced Tuesday that it has voluntarily withdrawn its application to the Food and Drug Administration for its dengue vaccine, making it unclear when or if the vaccine will be licensed in this country. The company said in a press release that it will review whether to proceed with trying to bring the vaccine to the U.S. market. The vaccine has already been approved in the European Union, the United Kingdom, Brazil, Argentina, Indonesia, and Thailand.

Vaccines 231

Vaccines 231

PharmaVoice

JULY 11, 2023

With a purchase of the pharma giant’s Kenilworth campus, Onyx Equities is looking to make the spot a go-to biotech hub.

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189

STAT

JULY 11, 2023

Melanie Lawrence doesn’t think she’ll live long enough to see her son graduate college. Lawrence, a patient with cystic fibrosis from Massachusetts, has been on antibiotics almost her whole life. Throughout her childhood and early teenage years, the antibiotics were “highly effective,” but with Lawrence now in her 40s, “the bacteria in my lungs are resistant to nearly all antibiotics,” she told the Senate HELP subcommittee on primary health & retirem

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Pharmaceutical Commerce

JULY 11, 2023

The National Alliance of Healthcare Purchaser Coalitions releases resources for employers/health plan purchasers to offer insights on PBMs role in high prescription drug costs.

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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

JULY 11, 2023

Frustration was boiling into open conflict within NaviHealth, a company that uses computer predictions to help control the cost of caring for millions of older and disabled Americans on privatized Medicare plans. The source of the outrage was not a customer or a salesperson, but an algorithm — specifically one that was being used to predict the amount of care needed by seriously ill patients.

Communication 190

Communication 190

Digital Pharmacist

JULY 11, 2023

With reimbursements dwindling and the so-called “ DIR Apocalypse ” or “DIR Armageddon” on the horizon, no explanation is needed as to why independent pharmacies are seeking innovative ways to expand their revenue streams beyond traditional prescription dispensing. By diversifying services and embracing a patient-centered approach, independent pharmacies can position themselves as vital healthcare hubs within their communities.

Independent Pharmacies 98

Independent Pharmacies Medication Therapy Management (MTM) Compounding Scheduling Appointments 98

PharmaVoice

JULY 11, 2023

After taking the reins from the company’s founding CEO, Douglas Treco is guiding Inozyme through the clinic.

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100

STAT

JULY 11, 2023

Japanese drugmaker Eisai said Tuesday that Ivan Cheung, chairman of its U.S. operations and global head of its Alzheimer’s disease unit, will retire at the end of the month. The surprise announcement comes just days after Eisai won final approval in the U.S. for its Alzheimer’s drug Leqembi. Cheung will be replaced in his capacity as head of the Alzheimer’s unit by his brother-in-law Keisuke Naito, 34, who is currently chief ecosystem officer and chief strategy officer.

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FDA Law Blog: Biosimilars

JULY 11, 2023

By Sara W. Koblitz — One of the most important questions FDA has to answer is whether a given product is appropriately characterized as a drug, biologic, device, food, cosmetic, or something entirely different. As we have explained before , that distinction is critical to assigning a particular product to the appropriate regulatory scheme. While it is exceedingly obvious that some products, like eyeshadow for example, are cosmetics, or a pacemaker is a device, it can get thorny where the disti

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STAT

JULY 11, 2023

“W hen I use a word,” one of 19th century British author and mathematician Lewis Carroll’s characters once said, “ it means just what I choose it to mean — neither more nor less.” Though he was a formidable philosopher and logician, Carroll likely would be stymied by the circular logic that justifies the definition of “recovery” currently used to support critical federal substance use disorder programs and activities.

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Pharmacy Management

Express Pharma

JULY 11, 2023

Lupin has received the Establishment Inspection Report (EIR) from the US FDA for its Pithampur Unit-2 manufacturing facility that manufactures oral solids and ophthalmic dosage forms. The EIR was issued post the last inspection of the facility conducted from March 21-29, 2023. The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI). “ We are pleased to have received the EIR from the US FDA with a satisfactory VAI status for our Pithampur U

Dosage 92

Dosage 92

STAT

JULY 11, 2023

Several thousand research fellows at the National Institutes of Health want to unionize, in large part because they want to raise their pay stipends to something resembling a living wage near the agency headquarters in Bethesda, Md. But with a Congress that is looking on in suspicion at the NIH’s research and a debt ceiling deal that limits budget increases, where is the money going to come from?

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BioPharma Dive

JULY 11, 2023

While the shot is approved in the EU, Takeda wasn’t able to address data collection issues raised by the US regulator in its current review cycle.

Vaccines 98

Vaccines 98

STAT

JULY 11, 2023

There’s growing evidence that DNA sequencing can help diagnose the health care system’s youngest patients — babies in their first year of life. But a new report resurfaces a thorny challenge in researchers’ quest to turn long strings of A’s, T’s, G’s, and C’s into information doctors and patients can use: Reading the genome is one challenge, interpreting it is another.

Hospitals 165

Hospitals 165

Express Pharma

JULY 11, 2023

Indoco Remedies received EU GMP certification from the Health Authority of Germany for its manufacturing site situated at L-32/33/34 Verna Industrial Estate, Goa. The European Agency conducted an inspection at Indoco’s manufacturing facility for solid oral dosage form in Goa (Plant -III) from April 20-25, 2023. The EU GMP certification issued by the German Health Authority (LAGeSo) confirms that the site complies with the Good Manufacturing Practice requirements as referred to in the EC Directiv

Dosage 80

Dosage 80

STAT

JULY 11, 2023

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.

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PhRMA

JULY 11, 2023

Recent studies add to the growing body of evidence questioning the value of the current 340B program and whether it’s benefiting patients as Congress intended.

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STAT

JULY 11, 2023

In 2006, when many Americans had barely heard the word “coronavirus,” Congress passed the Pandemic and All Hazards Preparedness Act (PAHPA), a landmark, bipartisan legislative framework that has successfully steered our nation’s biosecurity policy ever since. Before and during the worst of Covid, PAHPA’s authorities and programs served as the backbone of the country’s public health response, enabling the acceleration of medical countermeasure development via pu

Vaccines 148

Vaccines 148

BioPharma Dive

JULY 11, 2023

The companies’ decision to end their partnership on a TIGIT-blocking drug raises new doubts over a mechanism of action that has already produced setbacks for Roche and Merck.

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STAT

JULY 11, 2023

Top of the morning to you, and a fine one it is. Birds are chirping and cool breezes are wafting by the Pharmalot campus, where the official mascots are racing about the grounds. As for us, we are ensconced doing the usual sorts of things — updating our to-do list, brewing cups of stimulation (our choice today is chocolate raspberry) and foraging for items of interest.

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Biosimilars Drug Development 147

The Pharmacist

JULY 11, 2023

Pharmacy leaders and patient representatives have taken their concerns about the impact of medicines supply issues – including shortages and rising costs – to MPs in a special event held on Monday. During the meeting, MPs, including the former home secretary Priti Patel and former chief whip Wendy Morton, were told of the ongoing concerns […] The post MPs briefed on medicines supply issues appeared first on The Pharmacist.

Community Pharmacies 75

Community Pharmacies 75

Pharmaceutical Business Review

JULY 11, 2023

The label update reinforces the safety and effectiveness data of Leqvio generated by the VictORION clinical trial programme, claimed the company. Leqvio was initially approved by the FDA in December 2021. It is claimed to be the first and only small interfering RNA (siRNA) therapy to reduce LDL-C. The updated indication for primary hyperlipidemia enables the expanded use of Leqvio as an adjunct to diet and statin therapy beyond the earlier approved atherosclerotic cardiovascular disease (ASCVD)

Labelling 75

Labelling 75

The Pharmacist

JULY 11, 2023

Professor Claire Anderson was today elected as president of the Royal Pharmaceutical Society (RPS) for a further two years. She said that she had decided to stand again in order to offer ‘much needed continuity’ in a time of ‘unprecedented change’. And Alisdair Jones was elected unopposed as the new RPS treasurer, replacing outgoing treasurer […] The post Claire Anderson re-elected as RPS president appeared first on The Pharmacist.

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Orsini Pharmacy

JULY 11, 2023

Orsini Specialty Pharmacy, a leading independent specialty pharmacy focused on rare diseases and gene therapies, announced that BioMarin Pharmaceutical has selected it to dispense ROCTAVIAN™ ( valoctocogene roxaparvovec-rvox ). ROCTAVIAN is the first gene therapy for the treatment of severe Hemophilia A. For more information about ROCTAVIAN, see the Full Prescribing Information.

Specialty Pharmacies 75

Specialty Pharmacies 75

The Pharmacist

JULY 11, 2023

Pharmacists have shared concerns around the impact of GLP-1 and insulin shortages on patients and workload, while the Royal College of GPs highlighted risks to patient safety from unregulated semaglutide use. Shortages of GLP-1 receptor agonists are expected to continue for the next 18 months, with the Department of Health and Social Care (DHSC) citing […] The post Pharmacists and GPs call for diabetes drug supply protection appeared first on The Pharmacist.

Diabetes 70

Diabetes 70

PhRMA

JULY 11, 2023

I can still see everything in the hospital room in my mind’s eye, the night — 13 days before Christmas — a neurologist delivered the news to my mother and me that she had non-Hodgkin’s lymphoma, an aggressive tumor lodged in her brain. It threw our little family into a panic and into a search for the best treatment available in the subsequent 8 months before her death.

Hospitals 73

Hospitals 73

The Pharmacist

JULY 11, 2023

Independent charity Pharmacist Support has reported ‘significant increases’ in demand for its counselling support and financial assistance across Great Britain in 2022. In its annual impact report published this week, the charity said that it provided 911 funded counselling sessions to 133 people in 2022 – over three times as many sessions than the 290 […] The post ‘Significant increases’ in pharmacists accessing mental health and financial support appeared first on The Pharmacist.

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Pharma Times

JULY 11, 2023

Therapy treats patients with chronic graft-versus-host disease who have already received other treatments - News - PharmaTimes

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European Pharmaceutical Review

JULY 11, 2023

The first CD20xCD3 T-cell-engaging bispecific antibody (BsAb) treatment to be approved in Europe for diffuse large B-cell lymphoma (DLBCL) has been granted conditional marketing authorisation. European approval is based on results from the Phase I/II NP30179 study of Columvi ® (glofitamab). Given as a fixed course, the BsAb treatment induced a complete response (CR) in 35.2 percent of the heavily pre-treated or refractory DLBCL participants.

Hospitals 72

Hospitals 72

Pharma Times

JULY 11, 2023

It concerns the treatment being combined with platinum-containing chemotherapy - News - PharmaTimes

Chemotherapy 84

Chemotherapy 84

Pharmaceutical Technology

JULY 11, 2023

Iovance Biotherapeutics completes a preliminary analysis after the US' FDA found the trial design acceptable for accelerated approval.

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European Pharmaceutical Review

JULY 11, 2023

Contract research, development, and manufacturing organisation ( CRDMO ) WuXi Biologics has announced a proposed spin-off and separate listing of its subsidiary WuXi XDC Cayman Inc. (WuXi XDC) on the Main Board of the Hong Kong Stock Exchange (HKEX). A biologics CRDMO WuXi XDC is a joint venture between WuXi Biologics and WuXi STA. The organisation provides end-to-end contract R&D and manufacturing services for bioconjugates, including antibody drug conjugates (ADCs).

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Pharmaceutical Technology

JULY 11, 2023

Study shows patients taking abatacept, cenicriviroc, or Remicade in addition to SOC do not recover quicker compared to placebo.

Hospitals 74

Hospitals 74

cureatr

JULY 11, 2023

NEW YORK, July 11, 2023 — Cureatr, a national, value-based medication management services company improving quality and reducing total cost of care, and careMESH, a provider data platform focused on delivering healthcare communications to any clinician nationwide, are partnering to share patient medication action plans and clinical recommendations with providers through their preferred method of delivery.

Communication 58

Communication 58

pharmaphorum

JULY 11, 2023

TIGIT underwhelms again as Novartis ducks out Phil.

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