Cisplatin was first approved in 1978. Carboplatin followed in 1989. Nearly fifty years later, these drugs remain standard of care across virtually every solid tumor type in oncology. They are backbone treatments for lung cancer, ovarian cancer, bladder cancer, head and neck cancer, and testicular cancer. They are components of combination regimens with checkpoint inhibitors and ADCs. They are among the most prescribed oncology drugs in the world. And India—one of the world’s largest generic chemotherapy producers—is running out of both. Soaring platinum prices, higher import duties on platinum-group metals, and regulatory delays are making production financially unsustainable for Indian generic manufacturers. The shortage connects to the broader commodity disruption caused by the Iran war, which has driven up prices for energy, metals, and petrochemical-derived pharmaceutical inputs. When production becomes economically unviable in India, the supply chain effects reach every market that depends on Indian generics—including the United States. Separately, the FDA flagged patient deaths linked to Amgen’s rare disease drug Tavneos and called for its voluntary removal from the market. Biogen is pivoting to a partnership-driven model it calls “the new Biogen.” And layoffs continue across enGene, Neumora, and Genentech.
Top Story: India’s Cisplatin and Carboplatin Shortage Has Global Implications
What Happened: The Pharma Letter reported on June 16 that India is grappling with a severe shortage of cisplatin and carboplatin. The shortage is driven by three converging factors: soaring platinum prices, higher import duties on platinum-group metals, and regulatory delays that are preventing manufacturers from restarting or scaling production.
Why These Two Drugs Matter More Than Almost Any Other
Cisplatin and carboplatin are platinum-based chemotherapy agents that kill cancer cells by binding to DNA and preventing cell division. Their clinical utility is extraordinary: they are used as first-line or component therapy across lung, ovarian, bladder, head and neck, testicular, cervical, and gastric cancers, among others. In the era of immunotherapy, platinum-based chemotherapy has not been replaced—it has been combined. Keytruda plus cisplatin or carboplatin is the standard first-line regimen in non-small cell lung cancer. Padcev plus Keytruda (which showed 55.8% pathologic complete response at ASCO) is being evaluated alongside platinum-based chemotherapy in bladder cancer regimens. Nearly every major oncology clinical trial in solid tumors uses a platinum-containing comparator arm.
These drugs are generic, inexpensive, and foundational to modern oncology. They are also the kind of medicine that the pharmaceutical industry takes for granted—until the supply disappears.
The Economics of the Shortage
The shortage is fundamentally an economic problem. Platinum is the key raw material for both cisplatin and carboplatin. Global platinum prices have risen sharply due to supply disruptions in mining output, geopolitical factors including the Iran war’s impact on global commodity markets, and increased industrial demand from hydrogen fuel cell production and electronics manufacturing.
Indian generic manufacturers operate on thin margins. Domestic price controls cap what manufacturers can charge for essential medicines, including chemotherapy drugs. When the cost of platinum rises above the price at which manufacturers can profitably produce the finished drug, production stops. Indian manufacturers have reported that it now costs more to produce cisplatin and carboplatin than the regulated domestic price allows. The math no longer works.
Higher import duties on platinum-group metals compound the problem. And regulatory delays—the slow pace of manufacturing approvals, facility inspections, and production restart authorizations—prevent manufacturers from responding quickly even when they want to resume production.
The Global Supply Chain Risk
India is a major producer of generic platinum-based chemotherapy for both domestic use and global export. The United States, which sources a significant portion of its generic drug supply from India, is directly exposed to any sustained Indian production shortfall. This is the second India-specific supply chain disruption we have covered in 2026—the first was the API rerouting due to the Strait of Hormuz closure in May, when Evonik raised prices 15% and Indian API manufacturers faced dramatically higher transportation costs.
The platinum chemotherapy shortage is particularly concerning because these drugs are not easily substitutable. For many cancer types, there is no equivalent alternative to platinum-based chemotherapy. A hospital that runs out of cisplatin cannot simply switch to a different class of drug with the same efficacy—the treatment algorithm does not have a comparable backup for most indications. Treatment delays, protocol modifications, and potential interruptions to ongoing combination trials are all realistic consequences of a sustained shortage.
This is exactly the kind of supply chain vulnerability that the Section 232 tariff framework and the EU Critical Medicines Act were designed to address. But domestic manufacturing of generic platinum chemotherapy is not something that can be stood up quickly. The raw material sourcing, manufacturing infrastructure, and regulatory approvals required to produce these drugs at scale in the United States or Europe would take years to establish. Platinum refining is concentrated in a small number of countries (South Africa, Russia, Zimbabwe account for the vast majority of global production), and building a domestic pharmaceutical platinum supply chain would require securing raw material agreements that currently do not exist.
The irony is sharp: the Section 232 tariffs are designed to incentivize domestic manufacturing, but the tariff framework focuses on finished pharmaceutical products rather than the raw materials and generic drug production capacity that underpin the entire treatment infrastructure. A hospital can onshore its branded drug supply and still run out of cisplatin if the Indian generics pipeline breaks.
Our Pro brief analyzes how the platinum price surge threatens the global oncology treatment backbone, assesses U.S. exposure to the Indian supply shortfall, and identifies the alternative sourcing and formulation opportunities the shortage creates. [Details below.]
FDA Asks Amgen to Voluntarily Pull Tavneos Over Patient Deaths
What Happened: BioSpace reported that the FDA flagged patient deaths linked to Amgen’s rare disease drug Tavneos (avacopan, for ANCA-associated vasculitis) and called for its voluntary removal from the market. Amgen responded by recruiting an independent data analysis from Duke University researchers to build the case for the drug’s continued market approval.
What This Means for Post-Market Safety
A voluntary removal request is the FDA’s standard first step before initiating a mandatory withdrawal proceeding. The agency identified deaths it considers causally linked to Tavneos and determined that the drug’s risk-benefit profile no longer supports continued marketing. This is the most serious post-market safety action for a rare disease drug in 2026.
Amgen’s response—commissioning an independent analysis from Duke—is a strategy designed to challenge the FDA’s causal assessment. If the Duke researchers can demonstrate that the deaths are attributable to the underlying disease (ANCA-associated vasculitis is itself a life-threatening condition) or to confounding factors rather than to Tavneos, Amgen could argue for a label modification (additional warnings, restricted prescribing) rather than full market withdrawal.
The outcome matters beyond Tavneos itself. Rare disease drugs serve small patient populations with limited treatment alternatives. ANCA-associated vasculitis is a rare autoimmune condition that attacks blood vessels and can damage kidneys, lungs, and other organs. Tavneos provided a treatment option that reduces dependence on long-term corticosteroids—drugs that carry their own serious side-effect burden including bone loss, diabetes, weight gain, and immune suppression. Losing Tavneos would leave these patients with fewer options and potentially force them back onto the corticosteroid regimens that Tavneos was designed to replace.
The risk-benefit calculation for rare disease drugs is inherently different from mass-market therapies. When a drug serves a small population with a life-threatening disease and limited alternatives, regulators must weigh the safety signal against the clinical consequence of removing the only or best available treatment. A safety signal that would prompt straightforward withdrawal of a mass-market drug with multiple alternatives may warrant a different response for a rare disease drug where withdrawal leaves patients with no comparable option.
Amgen is betting that the Duke analysis will tip that calculation in favor of continued market access with enhanced safety monitoring rather than withdrawal. The precedent matters: if Amgen successfully uses independent academic analysis to challenge an FDA withdrawal request, other drugmakers facing post-market safety disputes will follow the same playbook. If the FDA proceeds with withdrawal despite the independent analysis, it sends a signal that post-market safety concerns will be treated with the same rigor as pre-approval requirements, regardless of unmet need or limited alternatives.
Biogen Pivots to “The New Biogen” Through Partnerships
What Happened: Biogen executives told Fierce Biotech on June 16 that the company is in the middle of a transition to “the new Biogen” by embracing partnerships and external investments.
What Changed
Biogen built its reputation and its franchise on internal R&D. The company’s most important products—Spinraza for spinal muscular atrophy, Tecfidera for multiple sclerosis—were internally discovered and developed. The culture, the talent, and the identity of the company were rooted in the belief that great science comes from within.
“The new Biogen” framing signals management is explicitly acknowledging that model is no longer sufficient. The company has recently consolidated felzartamab rights ($850 million, TJ Biopharma), received Breakthrough Therapy designation for salanersen (SMA), and advanced diranersen to Phase 3 for tau-mediated Alzheimer’s disease despite a Phase 2 miss. Each of these programs involves external partnerships or acquisitions rather than purely internal discovery.
The strategic pivot reflects the same dynamic driving M&A across the entire industry: the pace of external innovation has outstripped what any single company can generate internally. Lilly’s 12 deals. Pfizer’s Innovent partnership. BMS’s Hengrui collaboration. GSK’s Nuvalent acquisition. The most productive pipeline-building strategies in 2026 involve acquiring or licensing assets from external sources. Biogen is late to this model compared to its larger peers, but its smaller size may give it an advantage in integration—fewer deals to manage, deeper focus on each partnership, and a more targeted therapeutic strategy (neuroscience and immunology) than the platform-level breadth that Lilly is pursuing.
The question is whether a company whose culture and competitive identity are built on internal science can successfully transition to a partnership-driven model. The answer will determine whether Biogen remains an independent company or becomes an acquisition target itself.
Layoffs Continue: enGene, Neumora, Genentech
The biopharma workforce reduction trend continues into mid-June:
enGene halved its workforce in a cost-saving initiative. Neumora Therapeutics cut 35% of staff. And Genentech’s R&D restructuring reached a top executive who had been with the biotech for nearly 30 years—a particularly notable departure given Genentech’s legendary culture of scientific continuity.
These follow the Takeda 4,500 global cuts (May), Novartis biomedical research layoffs (May), Gilead’s 87% Arcellx workforce reduction (June), and Fulcrum’s 85% cut (June). The pattern remains consistent across the industry: companies are right-sizing around core therapeutic priorities while cutting programs and people that do not fit the strategic focus. The GLP-1 boom, the ADC wave, and the oncology M&A cycle are creating winners. The companies and programs that do not fit those narratives are bearing the cost.
The Genentech departure is worth noting separately. Genentech, as part of Roche, has historically been one of the most stable employer brands in biotech. When a 30-year veteran exits through restructuring, it signals that the restructuring is reaching deep into the organization—not just trimming the periphery but reshaping the core.
Strategic Themes
1. The India Chemotherapy Shortage Exposes the Most Dangerous Type of Supply Chain Vulnerability
Specialty drugs get the headlines. Generic chemotherapy keeps patients alive. Cisplatin and carboplatin are so foundational to oncology that their supply has been taken for granted for decades. The India shortage reveals what happens when commodity economics (platinum prices), trade policy (import duties), and regulatory friction (production restart delays) converge on a drug class that has no close substitutes. This is not a GLP-1 supply constraint where patients can wait or switch to an alternative. This is a cancer treatment supply constraint where delays directly affect patient outcomes.
2. The Tavneos Withdrawal Request Tests How Far the FDA Will Go on Post-Market Safety
The FDA asking Amgen to voluntarily pull a rare disease drug over patient deaths is the agency’s most aggressive post-market safety action of 2026. The outcome—withdrawal, label modification, or continued marketing with enhanced monitoring—will set a precedent for how post-market safety signals are adjudicated when they involve rare disease drugs with limited alternatives. Amgen’s decision to commission independent Duke analysis rather than comply immediately suggests the company believes the data support continued marketing.
3. “The New Biogen” Represents the Industry’s Broader Shift from Internal R&D to External Innovation
Biogen joining the external innovation model is not a surprise—it is an inevitability. The pace of external innovation has outstripped internal R&D capacity at every major pharmaceutical company. What distinguishes Biogen’s pivot is the explicit acknowledgment: management is telling the market that the old model is insufficient and the new model is partnership-driven. Whether the transition succeeds depends on execution, cultural adaptation, and the quality of the external assets Biogen acquires and licenses.
4. The Layoff Pattern Tells You Where the Industry Is and Is Not Investing
Cuts at enGene, Neumora, Genentech, Arcellx, Fulcrum, Takeda, and Novartis. Hiring at Lilly (12 acquisitions to integrate), Revolution Medicines (commercial buildout), and companies across the GLP-1 and ADC ecosystems. The industry is not shrinking—it is reallocating. Capital and talent are flowing toward GLP-1 obesity, RAS oncology, ADC combinations, in vivo CAR-T, and precision medicine. They are flowing away from programs and companies that do not fit those priorities. The layoffs are the negative image of the M&A wave: both reflect the same strategic concentration.
Frequently Asked Questions
What is the India chemotherapy shortage?
India is experiencing a severe shortage of cisplatin and carboplatin, two foundational chemotherapy drugs used across virtually every solid tumor type. Soaring platinum prices, higher import duties, and regulatory delays have made production financially unsustainable for Indian generic manufacturers.
Why does this matter globally?
India is a major producer of generic platinum-based chemotherapy for domestic use and global export. The United States sources a significant portion of its generic drug supply from India. A sustained Indian production shortfall could affect cancer treatment protocols worldwide. These drugs are not easily substitutable—there is no equivalent alternative for most indications.
What is happening with Tavneos?
The FDA flagged patient deaths linked to Amgen’s rare disease drug Tavneos (avacopan, for ANCA-associated vasculitis) and called for its voluntary removal from the market. Amgen recruited Duke University researchers to conduct an independent analysis challenging the FDA’s causal assessment.
What is “the new Biogen”?
Biogen executives described a strategic pivot from the company’s historically internal R&D model to one emphasizing partnerships and external investments. Recent moves include consolidating felzartamab rights ($850M), receiving Breakthrough Therapy for salanersen (SMA), and advancing diranersen to Phase 3 for Alzheimer’s.
Which companies are laying off?
enGene (halved workforce), Neumora (35% cut), Genentech (restructuring reached a 30-year executive). These follow Takeda (4,500), Gilead/Arcellx (87%), Fulcrum (85%), and Novartis biomedical research cuts earlier this year.
When is BIO International?
June 22 to 25 in San Diego. Five days out. The industry’s largest partnering event.
BioMed Nexus Pro — What Institutional Subscribers Are Reading Today
Platinum and Chemo. We analyze how the commodity price surge threatens the global oncology treatment backbone, assess U.S. exposure to Indian generic supply shortfalls, and identify alternative sourcing strategies and formulation opportunities the shortage creates.
Tavneos. We assess what the FDA’s voluntary withdrawal request means for post-market safety enforcement in rare disease, how Amgen’s Duke analysis strategy could change the outcome, and what precedent the resolution sets for future post-market safety disputes.
Biogen’s Pivot. We evaluate whether “the new Biogen” partnership-driven model can work for a company built on internal R&D, compare the pivot to similar transitions at other mid-cap pharma companies, and assess whether Biogen’s neuroscience focus gives it a competitive advantage in the partnership market.
Plus: Layoff pattern analysis, India supply chain tracker, Revolution filing watch, BIO International preview, and the updated catalyst calendar through H2 2026.
About BioMed Nexus
BioMed Nexus delivers institutional-grade intelligence to biotech and pharma executives, investors, and clinicians. Our daily briefings and deep-dive analyses cut through the noise to deliver the strategic insights that drive better decision-making in the life sciences.
Subscribe to receive daily updates and gain access to BioMed Nexus Pro institutional intelligence briefs.
