India Sanjay Bhutani of Bausch & Lomb outlines why the medical devices sector in India is poised for substantial growth, bolstered by increased government support and a higher healthcare budget. He also explains how the 2023 National Medical Device Policy marks a significant shift towards recognizing the distinct needs of the…
Europe PharmaBoardroom was delighted to attend DIA Europe 2024 in Brussels earlier this month, bringing together a veritable who’s-who of the European and global regulatory community. The politicians, regulators, payers, patient advocates, industry representatives, and service providers in attendance were treated to a three-day buffet of engaging panels and townhalls with…
Global Gavi, the world’s largest vaccine-focused public-private partnership has a new leader. Pakistani Senator Dr Sania Nishtar has officially assumed the role of CEO following a period of leadership uncertainty for the organisation and must now lay out Gavi’s strategic plan for 2026 to 2030, as well as convince its partners…
USA Online pharmacies have still not captured a large share of the fragmented US pharma market, but Eli Lilly’s partnership with Amazon after a direct-sale initiative of its own may serve to shake up the establishment and show what a direct-to-consumer model can offer. Eliminating the Middleman, or Not Amazon…
Saudi Arabia Halal pharmaceuticals, or medicines produced according to Islamic dietary laws, presented a global market worth some USD 100 billion in 2019, yet much of halal pharmaceuticals’ potential remains untapped. In conversation with PharmaBoardroom, Mazen M. Hassanain, co-founder and managing director of SaudiVax, a pioneer in halal vaccines, discusses the development…
USA The COVID-19 pandemic looked like a turning point for vaccines, but while R&D has made tremendous strides with ground-breaking platform technologies and mRNA, vaccines continue to attract fewer investments than areas such as oncology. As panel members at the “Reviewing Vaccine Pipeline Breakthroughs and Barriers” session during BIO’s recent CEO…
Germany The biggest pharma industry and healthcare stories from Germany, including the country’s legalisation of cannabis; the MASH potential of Boehringer Ingelheim’s obesity candidate; Bayer’s further share price drop and expansion into the US; the antibody-drug conjugate (ADC) specialist Tubulis’ series B2 financing, and Novartis’ deal with biotech MorphoSys. Germany’s…
Saudi Arabia Maher Abouzeid outlines Medserve’s role as a healthcare projects incubator, focusing on identifying and filling gaps in healthcare services across the Middle East & Africa region. Their hands-on approach includes conducting market assessments, securing funding, and assembling operational teams. Abouzeid also explains the company’s latest venture, Ardens Health, the first…
USA At the American trade association’s latest CEO & Investor Conference, the board chair of the Biotechnology Innovation Organization (BIO) Ted W. Love discussed US policies and speculated about the impact of the upcoming American election on the industry while affirming that biotech continues to thrive in spite of recent challenges.…
Pharma Legal Handbook 1. Please describe the main cost containment policies in place in your country and their fundamental principles a. Pricing and impact of generic/biosimilar approval Currently there are no policies in place in this regard. b. Clawback/Payback/Discounts/Rebates In Portugal, the main mechanism for cost-containment is the prior evaluation, regulated…
India Clinical trials will be a pivotal part of India’s attempts to scale the global pharmaceutical value chain. Following a series of well-publicised scandals in the early 2010s, the country tightened up its clinical research regulations and saw a significant drop in trial numbers. However, with a revised regulatory landscape, a…
Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials do not have to be conducted locally as a condition for marketing approval. This is not one of the prerequisite conditions for approval of the clinical trial protocol, which…
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