Mon.May 27, 2024

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The doctor would treat her sickle cell pain crisis — if she promised not to get an abortion

STAT

Here are some things A. was told when she arrived at the hospital one night in June 2023. That she couldn’t have the pain medicine she usually got for a sickle cell crisis because she was six weeks pregnant, but she could have Tylenol. That if she just took her blood thinner everything would be fine. That she needed to leave, and if she still felt bad by the time she’d wheelchaired out into the parking lot, she could turn around and check herself back into the emergency room.

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AZ’s Dato-DXd misses survival endpoint in lung cancer trial

pharmaphorum

The overall survival (OS) data has come in from the TROPION-Lung01 study of AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (Dato-DXd) in lung cancer – and the result likely isn’t what they were hoping for.

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Opinion: The world needs the new pandemic treaty

STAT

At the height of the Covid-19 pandemic, 25 heads of government issued an extraordinary call for a new international treaty for preventing, preparing for, and responding to pandemics. For two years, World Health Organization member states have been negotiating an international agreement scheduled for adoption at the World Health Assembly this month. Yet, late Friday in Geneva, negotiations ground to a halt.

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Improving stem cell transplantation success in high-risk blood cancers

European Pharmaceutical Review

Repurposing cyclophosphamide may enable more patients with high-risk blood cancers to receive transplanted stem cells from unrelated, partially matched donors, new research suggests. These new findings, which are part of an ongoing Phase II study , will be presented at the 2024 American Society of Clinical Oncology (ASCO) meeting and the European Hematology Association ( Abstract #6503 ).

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From Payroll Pains to Growth Gains: Streamlining Payroll & HR for Success

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.

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STAT+: Duchenne muscular dystrophy drug from Nippon Shinyaku fails in rare confirmatory trial

STAT

Japanese drugmaker Nippon Shinyaku said on Monday that its Duchenne muscular dystrophy drug, Viltepso, part of a controversial class of treatments for the rare disease, had failed to reach its primary endpoint in a placebo-controlled confirmatory trial. Children who received the drug could stand up faster from the floor at the end of the study, but so could children who received a placebo.

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Sanofi, Formation Bio and OpenAI announce first-in-class AI collaboration

World Pharma News

Sanofi, Formation Bio and OpenAI are collaborating to build AI-powered software to accelerate drug development and bring new medicines to patients more efficiently. The three teams will bring together data, software and tuned models to develop custom, purpose-built solutions across the drug development lifecycle. This represents a first collaboration of its kind within the pharma and life sciences industries.

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Nippon Shinyaku’s DMD drug fails confirmatory trial

pharmaphorum

The future of Nippon Shinyaku’s Duchenne muscular dystrophy (DMD) therapy Viltepso has been thrown into doubt after it failed a confirmatory clinical trial

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Non-injectable medication development remains significant unmet need in female infertility: GlobalData

Express Pharma

Great progress has been made in the management of female infertility since the introduction of assisted reproductive technology, predominantly in vitro fertilisation (IVF). However, despite the improvements made in the space, challenges associated with the treatment remain. The development of non-injectable fertility medications represents a significant unmet need, according to key opinion leaders (KOLs) interviewed by GlobalData.

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FDA sets date for Sarclisa in first-line multiple myeloma

pharmaphorum

Sanofi should hear from the FDA in September about its filing for Sarclisa as a first-line therapy for multiple myeloma after a priority review

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Andelyn Biosciences selected to manufacture AAV therapies under CIRM

Express Pharma

Andelyn Biosciences, a patient-focused cell and gene therapy Contract Development and Manufacturing Organisation (CDMO), has been selected to manufacture adeno-associated vectors (AAV) therapies using its suspension AAV Curator Platform under the California Institute for Regenerative Medicine (CIRM) Accelerating Medicines Partnership (AMP) Bespoke Gene Therapy Consortium (BGTC).

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

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.

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Lilly ups spend on diabetes, obesity drug production to $9bn

pharmaphorum

Eli Lilly is determined not to be left behind when it comes to manufacturing capacity for new diabetes and obesity therapies, raising its spending on a new plant in Indiana, US, to $9 billion.

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Malay Vyas appointed President & Business Head of STEER America

Express Pharma

STEER World, a company engineering innovation, specialising in materials transformation technologies, announced the appointment of Malay Vyas as President and Business Head of STEER America, to reinforce its US business. Malay brings over 20 years of experience and leadership to this role. Based in Houston, Texas, Vyas aims to play a key role in shaping the strategic direction, fostering innovation & leading long-term growth and sustainability initiatives in the region.

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EMA validates MAA for Prolia and Xgeva (denosumab) biosimilar candidate HLX14

Pharmaceutical Business Review

Denosumab has secured approval in several countries and regions under different trade names for a range of several indications such as for osteoporosis treatment in postmenopausal women who are at high risk for fracture, among others. In 2019, it was estimated that 32 million Europeans aged 50 or above had osteoporosis, of which 25.5 million were women.

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Asahi Kasei Medical completes new assembly plant for Planova virus removal filters

Express Pharma

Asahi Kasei Medical has completed the construction of its third assembly plant for Planova virus removal filters in Nobeoka, Miyazaki, Japan, and held its completion ceremony on May 24, 2024. The bioprocess business of Asahi Kasei Medical comprises Planova virus removal filters and equipment used in the manufacturing process of biotherapeutic products such as biopharmaceuticals and plasma derivatives, biosafety testing services, and biopharmaceutical Contract Development and Manufacturing (CDMO)

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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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Women advised to pair effective contraception with ‘skinny jabs’

The Guardian - Pharmaceutical Industry

Amid baby boom reports linked to drugs such as Wegovy and Ozempic, experts say it would be ‘wise’ to take extra precautions Claims that “skinny jabs” are fuelling an unexpected baby boom have led experts to warn women to pair their use with effective contraception. Medications such as Wegovy and Ozempic, both of which contain semaglutide, have become hugely popular, not least because they can help people lose more than 10% of their body weight.

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HOF Pharma targets global expansion

Express Pharma

With an aim to enhance its global presence and deliver high-quality medicines to a broader market, the Ahmedabad based, HOF Pharmaceuticals has shared its plans for growth. In two years, HOF Pharma has established itself as a manufacturer and exporter of tablets, capsules, and oral liquids. Reportedly, the company’s plant at Sanand, Ahmedabad meets stringent international standards.

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Drug Patent Expirations for the Week of May 26, 2024

Drug Patent Watch

ACULAR LS (ketorolac tromethamine) Abbvie Patent: 9,216,167 Expiration: May 28, 2024 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.

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Good Monk raises Rs. 7 crores in pre-series A round

Express Pharma

Multiply Ventures, Sharrp Ventures and Thinkuvate (Singapore based fund) come on board to partner with Superfoods Valley (Parent co. for Good Monk). Superfoods Valley, a Bangalore-based Nutrition start-up, announced a successful fundraiser of Rs.7 crores in Pre-Series A round. This investment is earmarked for scaling its flagship brand, Good Monk, which offers a unique range of nutrition mixes & instant fruit drink mixes.

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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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Jennifer Newberger Returns to HPM as a Director After Stints with Apple, Abbott Laboratories, and Cognito Therapeutics

FDA Law Blog: Biosimilars

Hyman, Phelps & McNamara, P.C. (HPM) proudly announces the return of Jennifer Newberger as a Director, further boosting its already robust medical device practice. Jennifer’s combination of experiences as in-house counsel for both large and start-up companies as well as outside counsel provides clients invaluable expertise and problem-solving skills.

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Pharma Pulse 5/27/24: Cyberattack at Ascension Hospitals Causing Delays in Patient Care, Optimizing Pharmaceutical Innovation Through AI & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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New patent expiration for Abbvie drug ACULAR LS

Drug Patent Watch

Annual Drug Patent Expirations for ACULAR+LS Acular Ls is a drug marketed by Abbvie and is included in one NDA. It is available from three suppliers.

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Pharma Pulse 5/27/24: New Study on Physician Compensation, Overwork, and Shortage, Evolving Clinical Research & more

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Study Uncovers Demographic Disparities in Access to AutoHCT Therapy for Patients with Multiple Myeloma

Pharmacy Times

UC Davis Health researchers uncover substantial treatment disparities and inequal access to autologous hematopoietic cell transplantation therapy among multiple myeloma patients.

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Express Scripts Announces New Independent Pharmacy Focused Strategy

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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South Korea’s MFDS approves Eisai-Biogen’s LEQEMBI for Alzheimer’s

Pharmaceutical Technology

South Korea has approved Eisai and Biogen’s LEQEMBI for adults with mild cognitive impairment due to mild Alzheimer's disease (AD).

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Study Finds Guidance Is Needed for Health Technology Assessments of Biosimilars

Pharmacy Times

Australia, Québec, and Sweden have defined processes for reimbursements by health technology assessments, but the United States has a low reliance rate.

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Dr. Reddy’s and Novartis sign distribution agreement for anti-diabetes products

Pharmaceutical Technology

Dr. Reddy's Laboratories' Russian subsidiary and Novartis Pharma signed a deal for the distribution of anti-diabetes products.

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Start With Why

RX Note

Introduction "Start With Why" , by motivational speaker Simon Sinek, dives deep into leadership and inspiration. It proposes a powerful concept: the Golden Circle. This framework flips the script on traditional communication. Most focus on the what (products or services) and the how (features and benefits). But Sinek argues the most inspiring leaders start with why: their core purpose, cause, or belief.

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Dimerix and Taiba enter DMX-200 commercialisation deal in Middle East

Pharmaceutical Technology

Dimerix has entered into an agreement with Taiba to commercialise DMX-200 for treating FSGS kidney disease in the Middle East.

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Resource Label Group Purchases Beyer Graphics

Pharmaceutical Commerce

The transaction serves as way to expand customers’ access to products and capabilities.

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Lilly doubles investment in Indiana site to enhance API manufacturing

Pharmaceutical Technology

Eli Lilly has annaounced a $5.3bn investment at its site in Lebanon, Indiana, US, to enhance API manufacturing capacity.

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Which pharmaceutical companies have the most drug patents in Lithuania?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Lithuania.

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Major manufacturing investment to support API production for tirzepatide

European Pharmaceutical Review

A new $5.3 billion investment for Eli Lilly and Company ’s manufacturing site in Lebanon, Indiana, US, increases the firm’s total investment there from $3.7 billion to $9 billion. This expansion will expand manufacturing capacity of active pharmaceutical ingredients (APIs) for Zepbound ® (tirzepatide) injection and Mounjaro ® (tirzepatide) injection.

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