Tue.Feb 06, 2024

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Opinion: Aduhelm was a mess — and it could happen again

STAT

Last week, Biogen announced it will cease both the study and sale of Aduhelm, its FDA-approved monoclonal antibody for the treatment of Alzheimer’s disease. Its decision, the company explained, is not a response to new data about the drug’s safety or efficacy, but instead “a reprioritization of resources.” Simply put, it wasn’t about science or medicine.

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Why a former BMS exec calls her new CEO role ‘unfinished business’ in cancer care

PharmaVoice

With a focus on her “three pillars” of being a CEO, Caroline Loew explains how she’s building a new company culture at an Alkermes spinoff — and a pipeline that offers a next-gen approach to oncology.

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Opinion: The Philips CPAP nightmare exposes shortcomings in medical device regulation

STAT

Millions of Americans’ bedtime routine includes wearing a mask attached to a respiratory machine that pushes air into their lungs, supporting their breathing during sleep. These airway pressure machines, known as CPAP or BiPAP depending on their design, are sophisticated medical devices that have been used for decades by patients with sleep disorders like obstructive sleep apnea.

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‘Beginning of the end’ for small molecules? VCs brace for Medicare investment gap

PharmaVoice

The "small molecule penalty" becomes even riskier for investors as the IRA negotiates prices, and VCs and lawmakers are looking to get a jump on those headwinds.

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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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STAT+: Colombia proceeds with plans to issue a compulsory license for an HIV medicine sold by GSK’s ViiV

STAT

The Colombian government has taken a significant step toward issuing a compulsory license for a widely used HIV treatment, the latest instance in which cash-strapped governments battle with the pharmaceutical industry over the cost of medicines. The government issued a notice last week inviting companies to indicate whether they would be willing to supply a generic version of dolutegravir, which is made by ViiV Healthcare, a company that specializes in HIV treatments and is largely controlled by

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Alternative therapies are needed to combat the impending threat of AMR

Pharmaceutical Technology

The potentially disastrous consequences of antimicrobial resistance (AMR) were highlighted at the recent World Economic Forum Meeting 2024.

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More Trending

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RxP expands life sciences real estate portfolio in Mumbai with $150+mn investment

Express Pharma

Rx Propellant (RxP), a platform focused on providing real estate solutions, including research and development (R&D) laboratories and associated facilities for the life sciences and associated sectors in India, has announced an initial investment of $75 million in phase 1 of the Navi Mumbai Research (NMR) District, as part of its continued regional expansion strategy across India.

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STAT+: Why Novartis is going to walk away from its acquisition of MorphoSys

STAT

Novartis said Monday that it intends to buy MorphoSys for just under $3 billion. The deal will not close. Six months from now, or sooner, Novartis will walk away — slightly embarrassed but otherwise unscathed — happy to pay a small breakup fee to MorphoSys to avoid owning a drug for myelofibrosis that regulators turned away. MorphoSys will not fare as well from the breakup.

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The Correlation Between a New York State Law Repeal and Vaccine Coverage in Schools

Pharmaceutical Commerce

A cohort study investigates the impact of Senate Bill 2994A and answers the question: does the repeal of school-entry nonmedical vaccination exemptions result in a rise in school vaccinations?

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STAT+: House panel passes key PBM reform for sliver of commercial market

STAT

WASHINGTON — A House panel passed a bipartisan bill to ban drug middlemen from charging fees based on drug list prices — the first in Congress’ raft of PBM reform efforts that would actually ban the practice in at least some of the employer-sponsored insurance market. The bill, by Rep. Mariannette Miller-Meeks (R-Iowa), would only allow PBMs to charge a flat service fee, separating those fees from list prices.

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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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A clearer harmony and attractiveness for EU Clinical Trials Regulation

pharmaphorum

For the latest episode of the pharmaphorum podcast, web editor Nicole Raleigh sat down with Chris Bamford, director of clinical trial regulatory management at IQVIA, and Shirley Rutter, associate director and strategic quality lead of global quality management at IQVIA Biotech.

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STAT+: Why Eli Lilly’s earnings didn’t quite live up to the hype

STAT

Eventually, the luckiest companies get to deal with a very particular problem: what to do when their stock could be getting ahead of itself. It’s a problem Eli Lilly got a little taste of Tuesday when it announced its full-year earnings. The drugmaker’s stock has more than doubled over the past 12 months due to the ever-increasing hopes for its GLP-1-based diabetes and weight-loss drug, sold under the brand names Mounjaro and Zepbound.

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Changing Faces: Pharma and biotech hires from January 2024

pharmaphorum

Stay updated with the latest news on hiring trends in the pharmaceutical and biotech industries. Learn about the companies and professionals making waves in the field from January 2024 in a new instalment of Changing Faces.

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STAT+: Medicare threatens to pull funding from HCA’s embattled Mission Hospital

STAT

Five years after investor-owned HCA Healthcare took over an esteemed nonprofit hospital in North Carolina, Medicare is threatening to cut off payment for any services it provides seniors. The rare and dramatic move follows a Medicare revelation that patient safety is in “immediate jeopardy” at Mission Hospital in Asheville. That designation is the most severe the agency can hand out.

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Cedars-Sinai mental health app launches on Apple Vision Pro

pharmaphorum

Right after the official launch of the new Apple Vision Pro mixed reality headset, Cedars-Sinai has launched a generative artificial intelligence (genAI) app that will use the technology to provide mental health support for patients.

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Vertex still knows how to do what it does best

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello, everyone. Damian here with a close read of the latest blockbuster deal, a look at Novartis’ multibillion-dollar gamble, and a reminder of what Vertex Pharmaceuticals does well.

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Study reveals blood test can pinpoint cause of brain injury in newborns

Pharma Times

Hypoxic-ischaemic encephalopathy affects around three million babies worldwide every year

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STAT+: Pharmalittle: We’re reading about a lawsuit against J&J, Express Scripts dealings, and more

STAT

Top of the morning to you, and a fine one it is. Clear blue skies and rays of sunshine are enveloping the Pharmalot campus, where the official mascots are busy waking the neighbors and assorted other creatures are moseying about. As for us, we are immersed in the usual routine, which starts with firing up the coffee kettle and brewing cups of stimulation.

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Medable's enhanced electronic consent making patients feel more human and less like study subjects

Outsourcing Pharma

Results from a new research project have been announced by technology provider Medable on the enhanced electronic informed consent (elC) in clinical trials.

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DHL Express India and Aragen LifeSciences sign GoGreen Plus partnership to reduce carbon emission

Express Pharma

DHL Express and Aragen LifeSciences, a leading provider of contract research, development, and manufacturing services for the global life sciences industry, jointly announced partnership to use DHL’s GoGreen Plus service. This pioneering collaboration makes Aragen the first Science Based Targets initiative (SBTi) customer of DHL Express in India. The GoGreen Plus service supports Aragen’s goal to reduce carbon emissions in international shipments.

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How to ensure brand planning success for 2024

pharmaphorum

Daniel Kohlstaedt, managing director at PurpleLeaf Strategy, discusses how new technologies can help pharmaceutical leaders plan for success during their upcoming brand planning cycle.

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RPS calls out ‘inertia’ as ethnicity attainment gap persists

The Pharmacist

The Royal Pharmaceutical Society (RPS) has called for action to address the attainment gap between Black and White pharmacy students that has continued 10 years after it was first reported. In particular, it highlighted actions that could be taken by community pharmacy placement providers, as well as other stakeholders involved in training and assessment, to […] The post RPS calls out ‘inertia’ as ethnicity attainment gap persists appeared first on The Pharmacist.

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Brainomix 360 platform helping decision making in stroke endorsed by NICE

Outsourcing Pharma

An artificial intelligence (AI)-powered tool from UK-based Brainomix was one of only two products to be endorsed by health assessor the National Institute of Health and Care Excellence (NICE).

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Vertex seeks swift review of new CF triple after ph3 readout

pharmaphorum

Vertex will use a priority review voucher to speed up FDA review of its new triple therapy for cystic fibrosis, which has just cleared a phase 3 programme

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Health Canada approves Chiesi’s MYALEPTA for lipodystrophy

Pharmaceutical Technology

Health Canada has approved Chiesi Global Rare Diseases’ MYALEPTA as a treatment for individuals with lipodystrophy, an ultra-rare condition.

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Rani Therapeutics announces promising phase 1 results for oral Stelara biosimilar

Outsourcing Pharma

Rani Therapeutics, a clinical-stage biotherapeutics company focused on the oral delivery of biologics, has announced encouraging results from its phase 1 study of RT-111, a RaniPill capsule containing an ustekinumab biosimilar, CT-P43.

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Metagenomi prices IPO and NeOnc joins list of hopefuls

pharmaphorum

Gene-editing startup Metagenomi and cancer specialist NeOnc Technologies have announced the terms of their initial public offerings

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Phesi's huge repository of data in its Trial Accelerator platform reaches 100 million milestone

Outsourcing Pharma

Phesiâs artificial intelligence (AI) driven platform, Trial Accelerator, has reached a milestone and now contains global data from more than 100 million patients.

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Suanfarma realigns brand to showcase innovative spirit

European Pharmaceutical Review

Suanfarma has announced a strategic rebranding initiative to reinforce Suanfarma’s position as a global player in the healthcare sector, both as a distributor of active pharmaceutical ingredients (APIs) and as a contract development and manufacturing organisation (CDMO) in the production of APIs. In this manner, Suanfarma´s sites, Cipan and Rovereto, are now acknowledged as part of a global and unified brand.

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More pharma M&A as Novartis snaps up MorphoSys for $2.9bn

pharmaphorum

Novartis has agreed to buy Germany's MorphoSys in a transaction that values the cancer-focused biotech at $2.

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New Year, New Aspirations

Pharmaceutical Commerce

Pharma Commerce's new style is built off of the back of our new and improved editorial calendar.

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Vertex announces positive results from trial for cystic fibrosis combination treatment

Pharmafile

Vertex Pharmaceuticals has announced positive results from its once-daily vanzacaftor/tezacaftor/deutivacaftor programme, the company’s phase 3 programme for the treatment of cystic fibrosis (CF). The programme included two randomised, double-blind, active-controlled, 52-week trials, SKYLINE 102 and SKYLINE 103, which assessed the efficacy of the drug combination in patients with CF aged 12 and older who have […] The post Vertex announces positive results from trial for cystic fibrosis com

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Pfizer partners American Cancer Society on health equity

pharmaphorum

A $15m initiative between Pfizer and the American Cancer Society aims to tackle unequal access to care in the US.

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Warning over ‘inappropriate business behaviours’ around Pharmacy First

The Pharmacist

The Pharmacists’ Defence Association (PDA) has seen evidence of ‘pressure to drive commercial imperatives’ being placed upon pharmacists around the delivery of Pharmacy First, it has said. In a statement issued last week, the pharmacy union claimed ‘some’ businesses were suggesting to pharmacists delivering Pharmacy First that ‘link selling pain relief preparations to patients is […] The post Warning over ‘inappropriate business behaviours’ around Pharmacy First appeared first on The Pharm

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Khosla Ventures’ Alex Morgan on biotech’s challenges and solving drug delivery

BioPharma Dive

The life sciences investor has backed a number of startups working on technologies for delivering and manufacturing cell and gene medicines.

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