Pallavur Sivakumar’s Post

New FDA requirements and the IRA will create complexity in the coming year for #pharmaceuticals. These seismic shifts make engineering document management for GMP documents more important than ever. Check out our Guide on Conquering Regulatory Compliance Chaos in Life Sciences https://lnkd.in/gb664cKU #pharmavoice #biomedicalengineering #pharmaceutical #gmp #documentmanagement https://lnkd.in/eM8RAs_W

Bristol Myers Squibb-Myers Squibb (BMY) reported earnings of $1.70 per share vs $1.52 on revenue of $11.48 billion vs $11.21 billion estimate for the fourth quarter ended December 2023. The company said it expects 2024 earnings of $7.10 to $7.40 per share. The current consensus earnings estimate is $7.06 per share for the year ending December 31, 2024. https://lnkd.in/eThbNf-a

Meet the Four Executives Headlining the Drug Channels Leadership Forum: Good news, everyone! We have secured four outstanding fireside chat participants for our inaugural Drug Channels Leadership Forum, which will be held next March in Miami. I’ll be leading one-on-one conversations with each of these executives: * Steven H. Collis, Chairman, President, and CEO, Cencora, Inc. * Patrick Conway, MD, MSc, CEO, Optum Rx * Frank Cunningham, Group Vice President, Global Value and Access & Lilly Direct, Eli Lilly and Company * Tim Wentworth, CEO, Walgreens Boots Alliance, Inc. Our fireside chats will illuminate crucial issues and key strategic concerns affecting the prescription drug market and the entire U.S. healthcare system. The event will also include panel discussions covering a range of important topics. Participants in these panels will be announced this fall. IMPORTANT: To maximize the value of networking and learning, the event will have a limited number of attendees. Click here to request an invitation. We will also have a limited number of sponsors. Click here to learn more about sponsorship opportunities. Read on for the full press release. Hope you can join us! Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute, an HMP Global Company. All rights reserved. This Feed is for personal non-commercial use only. #pbm #lifesciences #financial

BMS Decision to Lay Off 2,200 Employees Comes After M&A Spending Spree This week, several Big Pharma companies reported first-quarter 2024 financial results. Biogen beat Wall Street’s profit expectations and reported a spike in the uptake of its Alzheimer’s disease therapy Leqembi, and Novartis raised its 2024 outlook on strong drug sales. Meanwhile Roche’s Q1 sales slipped due to a continued drop in demand for COVID-19 products and the appreciation of the Swiss franc. However, the biggest news of the week was Bristol Myers Squibb’s announcement that it will reduce its headcount by 6%, laying off approximately 2,200 employees, or nearly 30% of all biopharma jobs lost so far in 2024, according to BioWorld. https://lnkd.in/eh8B-JDg

19 years of delivery quality healthcare products and services

Meet the Four Executives Headlining the Drug Channels Leadership Forum: Good news, everyone! We have secured four outstanding fireside chat participants for our inaugural Drug Channels Leadership Forum, which will be held next March in Miami. I’ll be leading one-on-one conversations with each of these executives: * Steven H. Collis, Chairman, President, and CEO, Cencora, Inc. * Patrick Conway, MD, MSc, CEO, Optum Rx * Frank Cunningham, Group Vice President, Global Value and Access & Lilly Direct, Eli Lilly and Company * Tim Wentworth, CEO, Walgreens Boots Alliance, Inc. Our fireside chats will illuminate crucial issues and key strategic concerns affecting the prescription drug market and the entire U.S. healthcare system. The event will also include panel discussions covering a range of important topics. Participants in these panels will be announced this fall. IMPORTANT: To maximize the value of networking and learning, the event will have a limited number of attendees. Click here to request an invitation. We will also have a limited number of sponsors. Click here to learn more about sponsorship opportunities. Read on for the full press release. Hope you can join us! Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute, an HMP Global Company. All rights reserved. This Feed is for personal non-commercial use only. #pbm #lifesciences #financial

📢 Lowest Rates for Operationalise Early Access Programmed Europe Expiring Soon 📢 Returning for it's third year, this meeting remains the premier European forum dedicated to defining global regulations and sharing real-world case studies for Early Access Programmes. From exploring the potential of harmonized regulatory frameworks to delving into best practices for establishing robust forecasting models for proactive supply planning, and identifying the types of data that are optimal for research and compliance, this summit is essential for those looking to revolutionize their Early Access Programmes in 2024. 📖 Access the full agenda: https://ter.li/f4tmrb Don’t miss out on the chance to gain invaluable insights from esteemed Early Access professionals, such as those from GSK, Roche, AstraZeneca, Boehringer Ingelheim, BeiGene, Gilead Sciences and many more, at the only European industry event dedicated to navigating complex regulatory and operational hurdles to improve global access to life changing therapeutics. This week is your chance to secure the largest discount on your registration, with savings up to £1,100 expiring midnight Friday, July 5! ✅ Secure your discounted pass here: https://ter.li/99pmr9

This is amazing news for the biopharma sector in Ireland and for foreign direct investment into Ireland! With the creation of 670 highly skilled jobs & an investment of €1 billion, MSD Ireland's expansion is a reflection of the strength of the sector and Ireland's continuing attractiveness as a world class investment destination! #InvestinCarlow #InvestinMeath #InvestinIreland #IDAIreland #FDI #investmentdestination IDA Ireland #biopharma Department of Enterprise, Trade and Employment Gemma Allen Joseph Fitzpatrick Michael Lohan Mark Kelly Paul Bailey #USinIreland #USInvestment

It’s official! The results from PatientView – The Corporate Reputation of Pharma, 2022 ANZ are in.   As ranked by patient groups across ANZ, we’re delighted to be ranked in the top #2 when it comes to overall corporate reputation and key indicators such as alignment with patient group strategy, patient centricity and transparency.   At Gilead, while we’re dedicated to developing innovative medicines for life-threatening illnesses, we recognise it takes more than medicines to address the challenges people and community face. We also know that we can’t do it alone.   We feel so privileged to work alongside passionate, hard-working patient groups to create long-term improvements in care and support for Australians with life-threatening diseases. And it’s to those patient groups we extend our heartfelt thanks for recognising Gilead.   Ref: Results from a survey conducted November 2022-February 2023 among 58 patient groups across Australia and New Zealand on the performance of eight pharmaceutical companies by PatientView, a UK-based research group.

Today Cencora PharmaLex and SwedenBIO hosted a Brain & Breakfast event on the EU joint HTA process that sparked engaging conversations and valuable insights! A big thank you to all participants for contributing to the lively discussions, and special appreciation to our esteemed panelists Niklas Hedberg and Hanna Zirath, Ph.D. from TLV and Sofia Heigis, CEO at Oncopeptides, for transparently sharing your invaluable insights. The discussion was excellently moderated by Herbert Altmann, head of Market Access and Pricing and Reimbursement Europe, Cencora PharmaLex.   Here are some key takeaways from our enriching discussion: 💡 Prioritize Preparation: It's essential for pharma/biotech companies to familiarize themself with the available information and materials continuously published by the EC and other competent experts to be adequately prepared. 💡 Emphasize Communication: Effective communication, interaction, and knowledge-sharing are pivotal both internally within organizations and externally between companies and regulatory authorities, especially 2025/26 during the implementation phase. 💡 X-functional collaboration: Implementing and integrated launch plan supported by research and development (R&D), market access, regulatory and other departments focusing on evidence generation for the new EU HTA process. 💡 Engage with Joint Scientific Consultation (JSC): Engaging in early scientific consultations presents a valuable opportunity to consider an optimal and robust evidence generation plan satisfying both regulatory and HTA bodies' requirements. 💡 PICO Considerations: The Joint Clinical Assessment (JCA) relies on the Population, Intervention, Comparator, and Outcome (PICO) framework for assessments. However, variations in healthcare systems and treatment guidelines among different nations will significantly influence how PICO criteria are applied in drug assessments. High quality input from Swedish affiliates or SMEs is critical to ensure a good discussion with TLV in Sweden.   Let's continue to foster collaboration and knowledge sharing for a brighter future in the pharmaceutical landscape!   Want to learn more? This can be a start: https://lnkd.in/dhG3mhrX #EUHTA #JCA #JSC #BrainAndBreakfast #PanelDiscussion #TLV #SwedenBIO #CencoraPharmalex #Collaboration #Pharmaceuticals