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      <title>Senators, experts agree country of origin not an Rx trade secret</title>
      <description>
        <![CDATA[The days of the U.S. FDA considering as trade secrets country-of-origin info for drugs and their ingredients have to end, the Senate Aging Committee was told at a Jan. 29 hearing on truth in drug labeling.]]>
      </description>
      <guid>http://www.bioworld.com/articles/728478</guid>
      <pubDate>Thu, 29 Jan 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/728478-senators-experts-agree-country-of-origin-not-an-rx-trade-secret</link>
    </item>
    <item>
      <title>Skinny labeling to get its day before the US Supreme Court</title>
      <description>
        <![CDATA[After passing on one skinny label case a few years ago, the U.S. Supreme Court agreed to delve into the dark hole the Federal Circuit has dug for drug label carveouts that allow generic drugs and biosimilars to come to market even though some indications of the reference drug may still be protected by exclusivities or patents. The high court granted cert Jan. 16 to Hikma Pharmaceuticals v. Amarin Pharma Inc., which revolves around Hikma’s marketing of its generic version of Amarin’s blockbuster drug, Vascepa (icosapent ethyl).]]>
      </description>
      <guid>http://www.bioworld.com/articles/728135</guid>
      <pubDate>Tue, 20 Jan 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/728135-skinny-labeling-to-get-its-day-before-the-us-supreme-court</link>
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      <title>Scinopharm wins US FDA approval of multiple sclerosis drug</title>
      <description>
        <![CDATA[Scinopharm Taiwan Ltd. received U.S. FDA approval for its generic version of glatiramer acetate injection, a treatment for multiple sclerosis.]]>
      </description>
      <guid>http://www.bioworld.com/articles/727788</guid>
      <pubDate>Tue, 06 Jan 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/727788-scinopharm-wins-us-fda-approval-of-multiple-sclerosis-drug</link>
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    <item>
      <title>Scinopharm wins US FDA approval of multiple sclerosis drug</title>
      <description>
        <![CDATA[Scinopharm Taiwan Ltd. received U.S. FDA approval for its generic version of glatiramer acetate injection, a treatment for multiple sclerosis.]]>
      </description>
      <guid>http://www.bioworld.com/articles/727686</guid>
      <pubDate>Mon, 05 Jan 2026 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/727686-scinopharm-wins-us-fda-approval-of-multiple-sclerosis-drug</link>
    </item>
    <item>
      <title>South Korea trade deal eases industry’s pharma tariff fears</title>
      <description>
        <![CDATA[The Korea Biotechnology Industry Organization on Oct. 30 welcomed the bilateral trade deal between the U.S. and South Korea announced during U.S. President Donald Trump’s state visit alongside the Asia-Pacific Economic Cooperation forum in Gyeongju, South Korea.]]>
      </description>
      <guid>http://www.bioworld.com/articles/725900</guid>
      <pubDate>Tue, 04 Nov 2025 08:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/725900-south-korea-trade-deal-eases-industrys-pharma-tariff-fears</link>
      <media:content url="https://www.bioworld.com/ext/resources/BW-source/2025/Donald-Trump-and-Lee-Jae-myung-10-30.webp?t=1761848731" type="image/jpeg" medium="image" fileSize="595818">
        <media:title type="plain">U.S. President Donald J. Trump (left) and South Korea President Lee Jae-myung at the ROK-U.S. summit</media:title>
        <media:description type="plain">U.S. President Donald J. Trump (left) and South Korea President Lee Jae-myung at the ROK-U.S. summit in Gyeongju-si, South Korea Oct. 29. Source: Office of the President Republic of Korea</media:description>
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      <title>US, South Korea trade deal eases industry’s pharma tariff fears</title>
      <description>
        <![CDATA[The Korea Biotechnology Industry Organization on Oct. 30 welcomed the bilateral trade deal between the U.S. and South Korea announced during U.S. President Donald Trump’s state visit alongside the Asia-Pacific Economic Cooperation forum in Gyeongju, South Korea.]]>
      </description>
      <guid>http://www.bioworld.com/articles/725690</guid>
      <pubDate>Thu, 30 Oct 2025 09:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/725690-us-south-korea-trade-deal-eases-industrys-pharma-tariff-fears</link>
      <media:content url="https://www.bioworld.com/ext/resources/BW-source/2025/Donald-Trump-and-Lee-Jae-myung-10-30.webp?t=1761848731" type="image/jpeg" medium="image" fileSize="595818">
        <media:title type="plain">U.S. President Donald J. Trump (left) and South Korea President Lee Jae-myung at the ROK-U.S. summit</media:title>
        <media:description type="plain">U.S. President Donald J. Trump (left) and South Korea President Lee Jae-myung at the ROK-U.S. summit in Gyeongju-si, South Korea Oct. 29. Source: Office of the President Republic of Korea</media:description>
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      <title>Abortion dispute active, FDA clears new generic pill </title>
      <description>
        <![CDATA[With U.S. President Donald Trump’s administration vocally opposed to abortion, the U.S. FDA has approved a new generic version of the pill that makes the procedure possible medically: mifepristone, once better known as RU-486.]]>
      </description>
      <guid>http://www.bioworld.com/articles/724728</guid>
      <pubDate>Fri, 03 Oct 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/724728-abortion-dispute-active-fda-clears-new-generic-pill</link>
    </item>
    <item>
      <title>New FDA fast track for repurposed drugs?</title>
      <description>
        <![CDATA[Breaking with its long-held, oft-recited mantra that observational studies are great for generating hypotheses but not as evidence for approval, the U.S. FDA is initiating the approval of leucovorin calcium tablets for patients with cerebral folate deficiency, a neurological condition that affects folate transfer into the brain.]]>
      </description>
      <guid>http://www.bioworld.com/articles/724385</guid>
      <pubDate>Tue, 23 Sep 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/724385-new-fda-fast-track-for-repurposed-drugs</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/FDA-icons-and-doctor.webp?t=1666903713" type="image/png" medium="image" fileSize="238204">
        <media:title type="plain">FDA icons and doctor</media:title>
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    </item>
    <item>
      <title>Ripples of IRA Rx price negotiations to be felt on competition</title>
      <description>
        <![CDATA[Three milestones expected to bring the reality of U.S. prescription drug price negotiations into focus are hovering on the horizon. First, the CMS is scheduled to publish its maximum fair prices (MFPs) for the round 2 selected drugs by Nov. 30. Then, on Jan. 1, the MFPs for the first round kick in, affecting not only the 10 selected drugs, but a dozen approved biosimilars referencing the three biologics in that round, 94 generics either approved or tentatively approved that reference the small molecules on the list, and perhaps other innovator drugs in the same therapeutic spaces. And by Feb. 1, CMS must publish the list of up to 15 drugs selected for negotiations for the 2028 price year. That list will be the first to include Part B drugs.]]>
      </description>
      <guid>http://www.bioworld.com/articles/723643</guid>
      <pubDate>Fri, 29 Aug 2025 09:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/723643-ripples-of-ira-rx-price-negotiations-to-be-felt-on-competition</link>
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        <media:title type="plain">Prescription drug bottle, pills shaped in $ sign</media:title>
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      <title>South Korea approves record number of biosimilars in 2024</title>
      <description>
        <![CDATA[South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.]]>
      </description>
      <guid>http://www.bioworld.com/articles/720003</guid>
      <pubDate>Tue, 06 May 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/720003-south-korea-approves-record-number-of-biosimilars-in-2024</link>
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        <media:title type="plain">Approved stamp</media:title>
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    <item>
      <title>South Korea approves record number of biosimilars in 2024</title>
      <description>
        <![CDATA[South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.]]>
      </description>
      <guid>http://www.bioworld.com/articles/719694</guid>
      <pubDate>Wed, 30 Apr 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/719694-south-korea-approves-record-number-of-biosimilars-in-2024</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/Approval-stamp-blue.webp?t=1588869735" type="image/png" medium="image" fileSize="255131">
        <media:title type="plain">Approved stamp</media:title>
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    <item>
      <title>Many US tariffs paused, pharma warned, EU put on notice</title>
      <description>
        <![CDATA[The on-again, off-again U.S. tariffs are off again, at least for now, for more than 75 countries that have reached out to the Trump administration to negotiate instead of retaliating. The 90-day pause will provide some breathing room for the med-tech industry. Pharmaceuticals and active pharmaceutical ingredients were among the few products exempted from the reciprocal tariffs, but that exemption for pharmaceuticals was expected to be short-lived. Meanwhile, pharma CEOs warned European Commission President Ursula von der Leyen April 8 that, unless the EU quickly changes its policy, pharmaceutical research, development and manufacturing is increasingly likely to be directed to the U.S.]]>
      </description>
      <guid>http://www.bioworld.com/articles/718990</guid>
      <pubDate>Wed, 09 Apr 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/718990-many-us-tariffs-paused-pharma-warned-eu-put-on-notice</link>
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        <media:title type="plain">Pill bottle spilling over EU flag</media:title>
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    </item>
    <item>
      <title>Biopharma exempt from US reciprocal tariffs, but not untouched</title>
      <description>
        <![CDATA[At first glance, it appears that biopharmaceuticals dodged the latest U.S. tariff bullet; med-tech, not so much. According to the executive order President Donald Trump signed in the Rose Garden late yesterday, pharmaceuticals are one of the few things exempt from the new country-by-country reciprocal tariffs that will be going into effect over the next week. However, U.S.-based manufacturers of both drugs and devices could face supply chain disruptions, further market restrictions and increased operating costs as the new tariffs take effect and other countries retaliate.]]>
      </description>
      <guid>http://www.bioworld.com/articles/718920</guid>
      <pubDate>Thu, 03 Apr 2025 11:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/718920-biopharma-exempt-from-us-reciprocal-tariffs-but-not-untouched</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Geographic-regions/US/Caution-tape-displaying-US-flag-tariffs.webp?t=1743715570" type="image/jpeg" medium="image" fileSize="277917">
        <media:title type="plain">Caution tape displaying US flag, tariffs</media:title>
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    <item>
      <title>As tariffs threaten US imports of APIs, companies reshore manufacturing</title>
      <description>
        <![CDATA[While the U.S. has historically led the global pharmaceutical industry by pursuing both continual innovation and high quality, those strengths could become areas of weakness in times of political uncertainty, according to PA Consulting expert Andy Prinz.]]>
      </description>
      <guid>http://www.bioworld.com/articles/718195</guid>
      <pubDate>Tue, 11 Mar 2025 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/718195-as-tariffs-threaten-us-imports-of-apis-companies-reshore-manufacturing</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/Vaccine-production.webp?t=1617391669" type="image/png" medium="image" fileSize="495496">
        <media:title type="plain">Pharmaceutical vial manufacturing</media:title>
      </media:content>
    </item>
    <item>
      <title>Ending ‘pill penalty’ challenges sacred cow status of IRA</title>
      <description>
        <![CDATA[Getting the Ensuring Pathways to Innovative Cures (EPIC) Act through the U.S. Congress to do away with the “pill penalty” in the Medicare drug price negotiations could require an epic effort, given the current politically fueled atmosphere on the Hill. With the Inflation Reduction Act (IRA), which created the negotiations, considered a signature achievement of the Biden administration, the negotiations have become, for many lawmakers, almost a sacred cow that can’t be touched. If anything, some of them want to expand the negotiations to more drugs and to the commercial market.]]>
      </description>
      <guid>http://www.bioworld.com/articles/718112</guid>
      <pubDate>Tue, 11 Mar 2025 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/718112-ending-pill-penalty-challenges-sacred-cow-status-of-ira</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/Pills-spilling-out-of-prescription-bottle.webp?t=1635883616" type="image/png" medium="image" fileSize="374430">
        <media:title type="plain">Pills spilling out of prescription bottle</media:title>
      </media:content>
    </item>
    <item>
      <title>As tariffs threaten US imports of APIs, companies reshore manufacturing</title>
      <description>
        <![CDATA[While the U.S. has historically led the global pharmaceutical industry by pursuing both continual innovation and high quality, those strengths could become areas of weakness in times of political uncertainty, according to PA Consulting expert Andy Prinz.]]>
      </description>
      <guid>http://www.bioworld.com/articles/718078</guid>
      <pubDate>Mon, 10 Mar 2025 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/718078-as-tariffs-threaten-us-imports-of-apis-companies-reshore-manufacturing</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/Vaccine-production.webp?t=1617391669" type="image/png" medium="image" fileSize="495496">
        <media:title type="plain">Pharmaceutical vial manufacturing</media:title>
      </media:content>
    </item>
    <item>
      <title>US Claims Court rules Vanda’s trade secrets not so secret</title>
      <description>
        <![CDATA[A U.S. Federal Claims Court judge shot down Vanda Pharmaceuticals Inc.’s accusations that the FDA disclosed the company’s trade secrets to generic competitors, finding that the trade secrets weren’t really secret or necessarily proprietary to Vanda.]]>
      </description>
      <guid>http://www.bioworld.com/articles/716598</guid>
      <pubDate>Fri, 24 Jan 2025 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/716598-us-claims-court-rules-vandas-trade-secrets-not-so-secret</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/Gavel-and-medication.webp?t=1614287344" type="image/png" medium="image" fileSize="303099">
        <media:title type="plain">Gavel and pill blister packs</media:title>
      </media:content>
    </item>
    <item>
      <title>Drugsplaining: Teva details price negotiation impact on generics</title>
      <description>
        <![CDATA[With more than five dozen generics already tentatively approved for 10 of the drugs selected for the next round of the Medicare Price Negotiation Program, the impact of the negotiations won’t be limited to just the brand drugs.]]>
      </description>
      <guid>http://www.bioworld.com/articles/716506</guid>
      <pubDate>Wed, 22 Jan 2025 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/716506-drugsplaining-teva-details-price-negotiation-impact-on-generics</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/Generic-drugs.webp?t=1588352361" type="image/png" medium="image" fileSize="183798">
        <media:title type="plain">Generic drugs and bottle</media:title>
      </media:content>
    </item>
    <item>
      <title>New US FTC report likely to fuel further PBM reforms</title>
      <description>
        <![CDATA[Pharmacy benefit managers (PBMs) are under the microscope again, this time for the price markups their affiliated specialty pharmacies charge for generic drugs used to treat cancer, HIV, multiple sclerosis and other serious conditions.]]>
      </description>
      <guid>http://www.bioworld.com/articles/716361</guid>
      <pubDate>Tue, 14 Jan 2025 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/716361-new-us-ftc-report-likely-to-fuel-further-pbm-reforms</link>
    </item>
    <item>
      <title>Should generics jump the queue in Wegovy parade?</title>
      <description>
        <![CDATA[Given the demand for Ozempic and Wegovy and the revenue the GLP-1 drugs are generating for Novo Nordisk A/S in the U.S., a lot of generic companies are clamoring to cash in on the drugs’ current popularity. And there are some U.S. lawmakers more than willing to oblige.]]>
      </description>
      <guid>http://www.bioworld.com/articles/712865</guid>
      <pubDate>Wed, 25 Sep 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/712865-should-generics-jump-the-queue-in-wegovy-parade</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/Ozempic-Wegovy-boxes-and-pens.webp?t=1727301418" type="image/jpeg" medium="image" fileSize="160786">
        <media:title type="plain">Ozempic and Wegovy pens and packaging</media:title>
        <media:description type="plain">Credit: Novo Nordisk A/S
</media:description>
      </media:content>
    </item>
    <item>
      <title>Glenmark settles US civil price-fixing allegations</title>
      <description>
        <![CDATA[Glenmark Pharmaceuticals Inc. USA agreed Sept. 4 to pay $25 million, based on its ability to pay, to resolve the Department of Justice’s civil allegations that it conspired to fix the U.S. price of pravastatin, a generic drug used to treat high cholesterol.]]>
      </description>
      <guid>http://www.bioworld.com/articles/712395</guid>
      <pubDate>Tue, 10 Sep 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/712395-glenmark-settles-us-civil-price-fixing-allegations</link>
    </item>
    <item>
      <title>Glenmark settles US civil price-fixing allegations</title>
      <description>
        <![CDATA[Glenmark Pharmaceuticals Inc. USA agreed Sept. 4 to pay $25 million, based on its ability to pay, to resolve the Department of Justice’s civil allegations that it conspired to fix the U.S. price of pravastatin, a generic drug used to treat high cholesterol.]]>
      </description>
      <guid>http://www.bioworld.com/articles/712313</guid>
      <pubDate>Thu, 05 Sep 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/712313-glenmark-settles-us-civil-price-fixing-allegations</link>
    </item>
    <item>
      <title>GSK, Prasco pressured to drop price of pediatric inhaler</title>
      <description>
        <![CDATA[Boehringer Ingelheim GmbH’s and Astrazeneca plc’s implementation of a $35 monthly U.S. price cap on inhalers for asthma and chronic obstructive pulmonary disease is adding to the pressure on Prasco Laboratories and GSK plc to follow suit with the pricing of an authorized generic of GSK’s Flovent (fluticasone propionate) inhaler.]]>
      </description>
      <guid>http://www.bioworld.com/articles/711654</guid>
      <pubDate>Thu, 15 Aug 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/711654-gsk-prasco-pressured-to-drop-price-of-pediatric-inhaler</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Money/Piggy-bank-filled-with-dollar-coins.webp?t=1722265123" type="image/jpeg" medium="image" fileSize="193287">
        <media:title type="plain">Piggy bank filled with dollar coins</media:title>
      </media:content>
    </item>
    <item>
      <title>GSK, Prasco pressured to drop price of pediatric inhaler</title>
      <description>
        <![CDATA[Boehringer Ingelheim GmbH’s and Astrazeneca plc’s implementation of a $35 monthly U.S. price cap on inhalers for asthma and chronic obstructive pulmonary disease is adding to the pressure on Prasco Laboratories and GSK plc to follow suit with the pricing of an authorized generic of GSK’s Flovent (fluticasone propionate) inhaler.]]>
      </description>
      <guid>http://www.bioworld.com/articles/711571</guid>
      <pubDate>Wed, 14 Aug 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/711571-gsk-prasco-pressured-to-drop-price-of-pediatric-inhaler</link>
    </item>
    <item>
      <title>Fed Circuit resuscitates skinny label infringement challenge</title>
      <description>
        <![CDATA[In reviving another case involving drug label carveouts, the U.S. Court of Appeals for the Federal Circuit insisted that its June 25 decision in <em>Amarin Pharma Inc. v. Hikma Pharmaceuticals plc</em> will not kill so-called skinny labels that allow generics to come to market when some of the brand’s indications still have patent protection.]]>
      </description>
      <guid>http://www.bioworld.com/articles/710006</guid>
      <pubDate>Wed, 26 Jun 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/710006-fed-circuit-resuscitates-skinny-label-infringement-challenge</link>
    </item>
    <item>
      <title>Still targeting Xtandi, groups ask CMS to do what NIH wouldn’t</title>
      <description>
        <![CDATA[Having failed in their efforts to get the U.S. NIH to march in on Xtandi’s patents under the Bayh-Dole Act because of price, Knowledge Ecology International and two other advocacy groups are now asking the Centers for Medicare & Medicaid Services (CMS) to do what the NIH refused to do. But rather than pressing for a march-in, which can be a lengthy process, the groups are pushing for CMS to use other statutory tools to clear the way for Xtandi (enzalutamide) generics to launch in the U.S. before Astellas Pharma Inc.’s three remaining patents for the prostate cancer drug expire in 2026 and 2027.]]>
      </description>
      <guid>http://www.bioworld.com/articles/707507</guid>
      <pubDate>Wed, 10 Apr 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/707507-still-targeting-xtandi-groups-ask-cms-to-do-what-nih-wouldnt</link>
      <media:content url="https://www.bioworld.com/ext/resources/Stock-images/Drugs/Generic-drugs.webp?t=1588352361" type="image/png" medium="image" fileSize="183798">
        <media:title type="plain">Generic drugs and bottle</media:title>
      </media:content>
    </item>
    <item>
      <title>US FDA struggling to keep up with clinical research inspections</title>
      <description>
        <![CDATA[The lingering effects of the COVID-19 pandemic and ongoing recruitment/retention issues are making it difficult for the U.S. FDA’s bioresearch monitoring program to keep up with the on-site clinical research inspections that are a cornerstone of the preapproval process for new drugs, biological products and medical devices. The resulting delays could threaten the approval timelines for many products.]]>
      </description>
      <guid>http://www.bioworld.com/articles/707278</guid>
      <pubDate>Thu, 04 Apr 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/707278-us-fda-struggling-to-keep-up-with-clinical-research-inspections</link>
      <media:content url="https://www.bioworld.com/ext/resources/BMT-source/2021/08-13-Blog-FDA.webp?t=1628871192" type="image/png" medium="image" fileSize="1092079">
        <media:title type="plain">Magnifying glass, FDA concept image</media:title>
      </media:content>
    </item>
    <item>
      <title>Teva, Janssen to continue squabble over schizophrenia drug patent</title>
      <description>
        <![CDATA[Yes, even a phase III protocol for a “failed” trial can constitute prior art, the U.S. Court of Appeals for the Federal Circuit told a lower court April 1 when it returned Janssen Pharmaceuticals Inc. and Teva Pharmaceuticals USA Inc.’s patent squabble for a do-over.]]>
      </description>
      <guid>http://www.bioworld.com/articles/707097</guid>
      <pubDate>Tue, 02 Apr 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/707097-teva-janssen-to-continue-squabble-over-schizophrenia-drug-patent</link>
    </item>
    <item>
      <title>US FDA: Fewer reserve drug samples needed</title>
      <description>
        <![CDATA[Thanks to technological advances, the U.S. FDA is reducing the quantity of reserve drug samples that must be retained from bioavailability and bioequivalence studies.]]>
      </description>
      <guid>http://www.bioworld.com/articles/707091</guid>
      <pubDate>Wed, 27 Mar 2024 12:00:00 -0400</pubDate>
      <link>https://www.bioworld.com/articles/707091-us-fda-fewer-reserve-drug-samples-needed</link>
    </item>
    <item>
      <title>GMP violations lead to US charges</title>
      <description>
        <![CDATA[A heads up for the biopharma and med-tech industries: The U.S. government is going beyond warning letters to slap companies for violating the FDA’s good manufacturing practice (GMP) regulations. KVK Research Inc., a U.S.-based generic drug manufacturer, pleaded guilty March 6 to two misdemeanor counts of violating the Federal Food, Drug and Cosmetics Act by introducing adulterated drugs into interstate commerce. As part of the plea, the company agreed to pay a proposed fine and forfeiture amount of $1.5 million.]]>
      </description>
      <guid>http://www.bioworld.com/articles/706365</guid>
      <pubDate>Wed, 06 Mar 2024 12:00:00 -0500</pubDate>
      <link>https://www.bioworld.com/articles/706365-gmp-violations-lead-to-us-charges</link>
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