All entries for: Biologic

April 25, 2024

Bristol Myers Squibb

Discontinued Drug, Discontinued Research

Princeton, NJ
10,001-50,000 employees
10001-50000 employees

Bristol Myers Squibb will cut 6% of its workforce in a restructuring meant to save $1.5 billion in costs by the end of next year.

The layoffs will affect some 2,200 employees, the company said Thursday. It’s also trimming its pipeline of experimental medicines, consolidating its array of offices and laboratories and reducing “third party” spending…

Bristol Myers’ growth in the near term will be hampered by looming patent expirations for its two top-selling drugs: the blood thinner Eliquis, which it sells with Pfizer, and the cancer immunotherapy Opdivo. Its third highest-grossing product, the multiple myeloma treatment Revlimid, already faces limited generic competition.

Eliquis is also one of the first 10 drugs the U.S. government has targeted for price negotiations under the Inflation Reduction Act, or IRA…

“While the IRA has an impact in the middle of the decade, we feel very good about being able to more than compensate for that with a very young and attractive growth profile coming from our … portfolio and the pipeline,” said Boerner, on a conference call with analysts.

The restructuring announced Thursday is another step, designed to prioritize products that Bristol Myers sees as having the highest potential. The company said it plans to reinvest the targeted $1.5 billion in savings in those opportunities.

Two-thirds of the savings is expected to come out of Bristol Myers’ spending on research and development. The company has discontinued 12 programs, including a successor version of its immunotherapy Yervoy, and will continue to review its pipeline through the rest of the year, Samit Hirawat, Bristol Myers’ chief medical officer, said on Thursday’s call.”

1 Discontinued Drug: Yervoy (biologic)
12 Discontinued Research Programs: Yervoy, unnamed research programs

Disease Area: Multiple, Oncology
Drug Type: Biologic, Small Molecule
April 24, 2024

BioMarin

Discontinued Drug, Discontinued Research, Layoffs

San Rafael, CA
1,001-5,000 employees
1001-5000 employees

As a result of its prioritized portfolio, four programs will be discontinued, including BMN 331, BMN 255, BMN 355 and BMN 365. None of the programs were discontinued due to safety signals.

4 Discontinued Drugs: BMN 331 (biologic), BMN 255 (biologic), BMN 355 (biologic), BMN 365 (biologic)
4 Discontinued Research Programs

Disease Area: Cardiology, Chronic Disease, Multiple, Rare Diseases
Drug Type: Biologic
December 5, 2023

IGM Biosciences

Discontinued Drug, Discontinued Research, Layoffs

Mountain View, CA
201-500 employees
201-500 employees

“The Company will continue to focus on the development of oncology and immunology and inflammation product candidates under its collaboration with Sanofi. In conjunction with this strategic refocusing, the Company will be reducing its workforce by approximately 22 percent…

“IGM continues to have a tremendous opportunity to transform a variety of disease areas using an entirely new class of antibody medicines,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “Although we are very encouraged by the clinical and preclinical data that we have generated for the programs we are halting, given the difficult conditions in the capital markets for our industry, we have decided to focus our capital resources on those opportunities that we believe have the most potential to produce significant near-term value. We are very sorry that some of our dedicated and talented employees will be leaving IGM as part of this strategic refocusing, and we wish to extend our sincere thanks and assistance to them in this difficult transition.”…

As a part of this strategic refocusing, the Company will halt the following clinical development activities:

Aplitabart in acute myeloid leukemia and in combination with birinapant
IGM-2644 (CD38 x CD3) in multiple myeloma
IGM-2537 (CD123 x CD3)
IGM-7354 (IL-15 x PD-L1)”

4 Discontinued Drugs: Aplitabart in acute myeloid leukemia (biologic), IGM-2644 (CD38 x CD3) in multiple myeloma (biologic), IGM-2537 (CD123 x CD3) (biologic), IGM-7354 (IL-15 x PD-L1) (biologic)
4 Discontinued Research Programs

Disease Area: Oncology
Drug Type: Biologic
November 13, 2023

IGM Biosciences

Negative Outlook

Mountain View, CA
201-500 employees
201-500 employees

“The implementation of cost containment measures, including the prescription drug provisions under the Inflation Reduction Act, as well as other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved.”

Disease Area: Multiple, Oncology
Drug Type: Biologic, Small Molecule
November 9, 2023

Xilio Therapeutics

Negative Outlook

Waltham, MA
51-200 employees
51-200 employees
Disease Area: Oncology
Drug Type: Biologic
November 9, 2023

Recursion Pharmaceuticals

Neutral Outlook

Salt Lake City, UT
201-500 employees
201-500 employees
Disease Area: Multiple, Oncology
Drug Type: Biologic, Small Molecule
November 9, 2023

Context Therapeutics

Negative Outlook

Philadelphia, PA
1-50 employees
1-50 employees
Disease Area: Oncology
Drug Type: Biologic
November 9, 2023

Beigene

Negative Outlook

Cambridge, MA
5,001-10,000 employees
5001-10000 employees

“For example, the Inflation Reduction Act of 2022 (“IRA”) contains several provisions that may impact our business to varying degrees, including provisions that reduce the out-of-pocket spending cap for Medicare Part D beneficiaries from $7,050 to $2,000 starting in 2025, thereby effectively eliminating the coverage gap; impose new manufacturer financial liability on certain drugs under Medicare Part D; allow the U.S. government to negotiate Medicare Part B and Part D price caps for certain high-cost drugs and biologics without generic or biosimilar competition; require companies to pay rebates to Medicare for certain drug prices that increase faster than inflation; and delay until January 1, 2032 the implementation of the U.S. Department of Health and Human Services (“HHS”) rebate rule that would have limited the fees that pharmacy benefit managers can charge. Further, under the IRA, orphan drugs are exempted from the Medicare drug price negotiation program, but only if they have one orphan designation and for which the only approved indication is for that disease or condition. If a product receives multiple rare disease designations or has multiple approved indications, it may not qualify for the orphan drug exemption.”

Disease Area: Oncology
Drug Type: Biologic
November 8, 2023

Adicet Bio

Negative Outlook

Boston, MA
51-200 employees
51-200 employees

“The implementation of the IRA is currently subject to ongoing litigation challenging the constitutionality of the IRA’s Medicare drug price negotiation program. The effects of the IRA on our business and the healthcare industry in general is not yet known.”

Disease Area: Oncology
Drug Type: Biologic
November 8, 2023

Pfizer

Neutral Outlook

New York, NY
50,001+ employees
50001+ employees

“The drug pricing provisions of the IRA, which was signed into law in August 2022, began to be implemented in 2023 and implementation efforts will continue over the next several years. In August 2023, the Biden Administration unveiled the first round of medicines subject to the “Medicare Drug Price Negotiation Program,” which requires manufacturers of select drugs to engage in a process with the Federal government to set new Medicare prices which would go into effect in 2026. Among the medicines included in the first round is Eliquis. We continue to evaluate the impact of the IRA on our business, operations and financial condition and results as the full effect of the IRA on our business and the pharmaceutical industry remains uncertain. In addition, changes to the Medicaid program or the federal 340B drug pricing program, including legal or legislative developments at the federal or state level with respect to the 340B program, could have a material impact on our business.”

Disease Area: Multiple, Oncology
Drug Type: Biologic, Small Molecule
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