PFIZER INC.

The US biosimilar market surged in 2024, driven by FDA approvals and looming patent cliffs, with 63 biosimilars approved and 42 launched. Innovator companies like Novartis, Biogen, Pfizer, and Amgen are entering biosimilar development to mitigate sales erosion. Challenges include market access, reimbursement barriers, and HCP/patient perception. Education and transparency are crucial for biosimilar adoption, with AI tools potentially aiding HCPs.

Merck's clesrovimab, awaiting FDA approval by June 2025, aims to protect newborns from RSV, competing with Sanofi and AstraZeneca's Beyfortus. RSV vaccines for young children are on hold due to safety concerns. Merck's clesrovimab could be available for ordering by July if approved.

FDA approved tapinarof cream 1% for atopic dermatitis in ages 2 and older, representing a non-steroidal option with a new mechanism of action. It improves skin barrier and reduces inflammation, showing a remittive effect. Over 80% of participants aged 2-17 in ADORING 3 trial achieved clear or almost clear skin, with 52% reporting completely clear skin.

New AI health care newsletter launching in February; Marty Makary's potential FDA leadership; Pfizer's 2025 financial guidance; Congress nearing PBM regulation deal; Adam Feuerstein's biopharma CEO list; Gameto announces first baby born via new stem-cell tech; Merck drops TIGIT and LAG-3 programs.

The ZEST trial, evaluating niraparib for breast cancer recurrence prevention in ctDNA-positive patients, failed due to insufficient enrollment. Lessons include starting ctDNA testing during treatment and focusing on high-risk patients. Median recurrence-free intervals were 11.4 months with niraparib vs. 5.4 months with placebo, though conclusions on efficacy are limited.

Digital transformation in pharma is crucial, with 75% of organizations implementing Pharma 4.0. Key drivers include patient demands, regulatory changes, and competition. Top technologies include AI, IoT, blockchain, and digital twins. Strategic insights focus on R&D, supply chain, marketing, and patient engagement.

Adjusting for principal components in genome-wide association studies can induce collider bias, especially in admixed populations where PCs may capture local genomic features instead of global ancestry. LD pruning is more effective than excluding high LD regions, but optimal parameters vary. Model-based ancestry inference may offer a better alternative in some cases. Careful pre-processing and checking of PCs are crucial to avoid spurious associations.

The FDA's accelerated approval pathway, enacted in 1992, has led to over 200 drugs reaching market based on surrogate endpoints. Despite recent withdrawals like Pfizer's Oxbryta and Takeda's Exkivity, the program has a strong track record, with over half of approvals converting to full approval. Challenges include failed confirmatory trials and the need for better biomarker understanding.

GSK announced that ViiV Healthcare, with Pfizer and Shionogi as shareholders, received a positive CHMP opinion for Vocabria in combination with J&J's Rekambys for treating HIV-1 in adolescents.

Pharma and biotech stocks like Viking Therapeutics, Vertex Pharmaceuticals, and Pfizer could be top performers by 2030 due to promising drug developments and market expansions.